Chrysalis Intelligence · Sponsors · Dexcom, Inc.

Dexcom, Inc.

San Diego, CA, US · 19 510(k) clearances · 6 PMAs · 21 recalls (10 Class I)

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Total clearances
19
2020-01-29 → 2026-08-11
Last 12 months
7
Product codes
5
Most recent
2026-08-11
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated Class II Clinical Chemistry 12 2026-06-08
SBH Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter Class II Clinical Chemistry 2 2026-08-11
SAF — — — 2 2026-05-21
QDK Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management Class II Clinical Chemistry 2 2021-08-17
QRX Continuous Glucose Monitor Informed Insulin Dose Calculator Class II Clinical Chemistry 1 2025-11-18
Class III

PMA approvals (6)

Total PMA records
6
Originals + supplements
Distinct product codes
1
First decision
2020-01-08
Most recent
2024-01-09
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2024-01-09 P120005-S091 G5 Mobile Continuous Glucose Monitoring System, G6 Continuous Glucose Monitoring System, G7 Continuous Glucose Monitorin Normal 180 Day Track No User Fee MDS Sensor, Glucose, Invasive Unknown
2023-01-12 P120005-S090 DEXCOM G5 Mobile Continuous Glucose Monitoring System Normal 180 Day Track No User Fee MDS Sensor, Glucose, Invasive Unknown
2022-01-20 P120005-S088 Dexcom G5 Mobile Continuous Glucose Monitoring System Normal 180 Day Track No User Fee MDS Sensor, Glucose, Invasive Unknown
2021-12-21 P120005-S089 G5 Mobile Continuous Glucose Monitoring System Real-Time Process MDS Sensor, Glucose, Invasive Unknown
2020-09-03 P120005-S087 G5 Mobile Continuous Glucose Monitoring System Normal 180 Day Track No User Fee MDS Sensor, Glucose, Invasive Unknown
2020-01-08 P120005-S086 Dexcom G5 Mobile Continuous Glucose Monitoring System 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
Safety

Recalls (21)

Class I (serious)
10
Risk of injury / death
Total recalls
21
Currently ongoing
18
Most recent
2026-05-27
DateSeverityStatusRecall # ProductCodeReason
2026-05-27 Class II Ongoing Z-2574-2026 Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack … — Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were late…
2026-04-14 Class II Ongoing Z-2165-2026 Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Numbe… — A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend …
2026-04-14 Class II Ongoing Z-2164-2026 Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Numbe… — A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend …
2026-04-14 Class II Ongoing Z-2163-2026 Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: S… — A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend …
2025-08-28 Class I Ongoing Z-0318-2026 Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model… — A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glu…
2025-07-24 Class I Ongoing Z-2450-2025 Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Numbe… — The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier)…
2025-07-24 Class I Ongoing Z-2449-2025 Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM App Model/Catalog N… — The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier)…
2025-07-24 Class I Ongoing Z-2448-2025 Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Numbe… — The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier)…
2025-07-24 Class I Ongoing Z-2447-2025 Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: S… — The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier)…
2025-07-24 Class I Ongoing Z-2446-2025 Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Numbe… — The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier)…
2025-05-12 Class I Ongoing Z-1946-2025 Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), … — Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or h…
2025-05-12 Class I Ongoing Z-1945-2025 Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-… — Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or h…
2025-05-12 Class I Ongoing Z-1944-2025 Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013 (MT26403-0),… — Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or h…
2025-05-12 Class I Ongoing Z-1943-2025 Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1) — Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or h…
2025-05-05 Class II Ongoing Z-1906-2025 Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) syste… — A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show …
2025-01-27 Class II Ongoing Z-1204-2025 Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001 — Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different…
2025-01-27 Class II Ongoing Z-1203-2025 Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001 — Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different…
2025-01-27 Class II Ongoing Z-1202-2025 Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001 — Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different…
2020-02-03 Class II Terminated Z-1562-2020 Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a gluco… — The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous G…
2020-02-03 Class II Terminated Z-1561-2020 Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a gluco… — The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous G…
2020-02-03 Class II Terminated Z-1560-2020 Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System i… — The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous G…
Filings

All 510(k) clearances (19)

Date K-number Device Code Class Specialty
2026-08-11 K262472 Stelo Glucose Biosensor System SBH Class II Clinical Chemistry
2026-06-12 K260935 Stelo Glucose Biosensor System SBH Class II Clinical Chemistry
2026-06-08 K261402 Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System QBJ Class II Clinical Chemistry
2026-05-21 K261359 Stelo Glucose Biosensor System SAF — —
2026-02-03 K253737 Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System QBJ Class II Clinical Chemistry
2025-12-17 K253710 Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System QBJ Class II Clinical Chemistry
2025-11-18 K252818 Dexcom Smart Basal QRX Class II Clinical Chemistry
2025-04-09 K243214 Dexcom G7 15 Day Continuous Glucose Monitoring System QBJ Class II Clinical Chemistry
2024-04-23 K240902 Dexcom G7 Continuous Glucose Monitoring System QBJ Class II Clinical Chemistry
2024-03-05 K234070 Stelo Glucose Biosensor System SAF — —
2024-02-26 K234133 Dexcom G7 Continuous Glucose Monitoring System QBJ Class II Clinical Chemistry
2023-05-15 K231081 Dexcom G7 Continuous Glucose Monitoring (CGM) System QBJ Class II Clinical Chemistry
2023-01-11 K223931 Dexcom G6 Continuous Glucose Monitoring (CGM) System QBJ Class II Clinical Chemistry
2022-12-07 K213919 Dexcom G7 Continuous Glucose Monitoring System QBJ Class II Clinical Chemistry
2022-07-29 K221259 Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System QBJ Class II Clinical Chemistry
2021-08-17 K203089 Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System QDK Class II Clinical Chemistry
2021-07-15 K201328 Dexcom G6 Continuous Glucose Monitoring (CGM) System QBJ Class II Clinical Chemistry
2020-12-04 K200876 Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System QBJ Class II Clinical Chemistry
2020-01-29 K193642 Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System QDK Class II Clinical Chemistry
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence