Chrysalis Intelligence · Sponsors · Abbott Diabetes Care, Inc.

Abbott Diabetes Care, Inc.

Alameda, CA, US · 11 510(k) clearances · 31 PMAs · 10 recalls (8 Class I)

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Total clearances
11
2020-06-12 → 2024-06-07
Last 12 months
0
Product codes
3
Most recent
2024-06-07
Name variants in FDA filings: Abbott Diabetes Care / Abbott Diabetes Care, Inc.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems Class II Clinical Chemistry 7 2023-02-21
QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated Class II Clinical Chemistry 3 2024-04-23
SBH Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter Class II Clinical Chemistry 1 2024-06-07
Class III

PMA approvals (31)

Total PMA records
31
Originals + supplements
Distinct product codes
2
First decision
2020-04-13
Most recent
2025-07-11
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2025-07-11 P160030-S057 FreeStyle Libre 14-Day Flash Glucose Monitoring System 30-Day Notice PZE Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated Unknown
2025-07-11 P150021-S060 FreeStyle Libre Pro Flash Glucose Monitoring System 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2024-04-05 P160030-S056 FreeStyle Libre 14 day Flash Glucose Monitoring System Normal 180 Day Track No User Fee PZE Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated Unknown
2023-11-21 P160030-S055 FreeStyle Libre 14 day Flash Glucose Monitoring System 30-Day Notice PZE Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated Unknown
2023-11-21 P150021-S059 FreeStyle Libre Pro Flash Glucose Monitoring System 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2023-06-30 P160030-S053 FreeStyle Libre 14 day Flash Glucose Monitoring System 30-Day Notice PZE Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated Unknown
2023-06-30 P150021-S058 FreeStyle Libre Pro Flash Glucose Monitoring System 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2023-01-17 P160030-S052 FreeStyle Libre 14-day Flash Glucose Monitoring System Normal 180 Day Track No User Fee PZE Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated Unknown
2022-04-28 P160030-S051 FreeStyle Libre 14 day Flash Glucose Monitoring System 30-Day Notice PZE Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated Unknown
2022-04-28 P150021-S057 FreeStyle Libre Pro Flash Glucose Monitoring System 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2022-03-16 P160030-S050 Freestyle Libre 14-Day Flash Glucose Monitoring System 30-Day Notice PZE Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated Unknown
2022-03-16 P150021-S056 FreeStyle Libre Pro Flash Glucose Monitoring System 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2022-03-02 P160030-S049 Freestyle Libre 14-Day Flash Glucose Monitoring System 30-Day Notice PZE Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated Unknown
2022-03-02 P150021-S055 FreeStyle Libre Pro Flash Glucose Monitoring System 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2022-01-19 P160030-S048 Freestyle Libre 14 day Flash Glucose Monitoring System Normal 180 Day Track No User Fee PZE Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated Unknown
2021-11-19 P160030-S044 Freestyle Libre 14-Day Flash Glucose Monitoring System 135 Review Track For 30-Day Notice PZE Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated Unknown
2021-11-19 P150021-S050 FreeStyle Libre Pro Flash Glucose Monitoring System 135 Review Track For 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2021-09-30 P150021-S054 FreeStyle Libre Pro Flash Glucose Monitoring System 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2021-09-01 P160030-S047 FreeStyle Libre 14-Day Flash Glucose Monitoring System Real-Time Process PZE Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated Unknown
2021-09-01 P150021-S053 FreeStyle Libre Pro Flash Glucose Monitoring System Real-Time Process MDS Sensor, Glucose, Invasive Unknown
2021-01-05 P160030-S046 FreeStyle Libre 14-Day Flash Glucose Monitoring System 30-Day Notice PZE Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated Unknown
2021-01-05 P150021-S052 FreeStyle Libre Pro Flash Glucose Monitoring System 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2020-12-16 P160030-S045 Freestyle Libre 14-Day Flash Glucose Monitoring System 30-Day Notice PZE Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated Unknown
2020-12-16 P150021-S051 FreeStyle Libre Pro Flash Glucose Monitoring System 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2020-07-30 P160030-S043 FreeStyle Libre 14-Day Flash Glucose Monitoring System 30-Day Notice PZE Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated Unknown
2020-07-30 P150021-S049 FreeStyle Libre Pro Flash Glucose Monitoring System 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
2020-05-21 P160030-S042 Freestyle Libre 14 day Flash Glucose Monitoring System Normal 180 Day Track No User Fee PZE Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated Unknown
2020-05-12 P160030-S039 Freestyle Libre 14 day Flash Glucose Monitoring System Normal 180 Day Track PZE Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated Unknown
2020-05-12 P150021-S046 FreeStyle Libre Pro Flash Glucose Monitoring System Normal 180 Day Track MDS Sensor, Glucose, Invasive Unknown
2020-04-13 P160030-S041 FreeStyle Libre 14-day Flash Glucose Monitoring System 30-Day Notice PZE Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated Unknown
2020-04-13 P150021-S048 FreeStyle Libre Pro Flash Glucose Monitoring System 30-Day Notice MDS Sensor, Glucose, Invasive Unknown
Safety

Recalls (10)

Class I (serious)
8
Risk of injury / death
Total recalls
10
Currently ongoing
9
Most recent
2025-11-24
DateSeverityStatusRecall # ProductCodeReason
2025-11-24 Class I Ongoing Z-1023-2026 FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component… — Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
2025-11-24 Class I Ongoing Z-1022-2026 FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component… — Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
2025-11-24 Class I Ongoing Z-1021-2026 FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component… — Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
2025-11-24 Class I Ongoing Z-1020-2026 FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the Fr… — Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
2024-07-24 Class I Ongoing Z-2692-2024 FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System — Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose results. The inaccurate higher glucose values may …
2023-07-12 Class II Ongoing Z-2414-2023 FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System — If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may displ…
2023-02-13 Class I Ongoing Z-1275-2023 FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring … — Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with rea…
2023-02-13 Class I Ongoing Z-1274-2023 FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monito… — Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with rea…
2023-02-13 Class I Ongoing Z-1273-2023 FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring Sy… — Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with rea…
2023-02-09 Class II Completed Z-0734-2024 FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System — If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experienced, due to app not connected, which cou…
Filings

All 510(k) clearances (11)

Date K-number Device Code Class Specialty
2024-06-07 K233861 Libre Rio Continuous Glucose Monitoring System SBH Class II Clinical Chemistry
2024-04-23 K233537 FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System QBJ Class II Clinical Chemistry
2023-04-13 K223435 FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System QBJ Class II Clinical Chemistry
2023-03-03 K222447 FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System QBJ Class II Clinical Chemistry
2023-02-21 K223537 FreeStyle Libre 2 System, FreeStyle Libre 3 System QLG Class II Clinical Chemistry
2022-05-26 K213996 FreeStyle Libre 3 Continuous Glucose Monitoring System QLG Class II Clinical Chemistry
2022-05-26 K212132 FreeStyle Libre 3 Continuous Glucose Monitoring System QLG Class II Clinical Chemistry
2021-11-22 K210943 FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) QLG Class II Clinical Chemistry
2021-08-11 K211102 FreeStyle Libre 2 Flash Glucose Monitoring System QLG Class II Clinical Chemistry
2021-07-30 K201761 FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) QLG Class II Clinical Chemistry
2020-06-12 K193371 FreeStyle Libre 2 Flash Glucose Monitoring System QLG Class II Clinical Chemistry
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence