Chrysalis Intelligence · Sponsors · Companion Medical, Inc.

Companion Medical, Inc.

San Diego, CA, US · 3 510(k) clearances · 1 recalls

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Total clearances
3
2020-02-10 → 2020-06-18
Last 12 months
0
Product codes
1
Most recent
2020-06-18
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NDC Calculator, Drug Dose Class II Anesthesiology 3 2020-06-18
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
1
Most recent
2022-11-08
DateSeverityStatusRecall # ProductCodeReason
2022-11-08 Class II Ongoing Z-0741-2023 InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA, MMT-105ELPKNA… — Diabetes management app may crash immediately upon opening, while using the app and/or while app is running in the background, which may lead to inability to us…
Filings

All 510(k) clearances (3)

Date K-number Device Code Class Specialty
2020-06-18 K201337 InPen System NDC Class II Anesthesiology
2020-02-18 K190487 InPen Dose Calculator NDC Class II Anesthesiology
2020-02-10 K192841 InPen System NDC Class II Anesthesiology
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence