510(k) Report

FDA applicant

Companion Medical, Inc.

San Diego, CA5 decisions2016–20202 recalls

FDA records 5 decisions for Companion Medical, Inc. (San Diego, CA) from 2016 to 2020: 5 510(k) clearances. Most are in product codes NDC (Calculator, Drug Dose) and FMF (Syringe, Piston). Since 2016 its 510(k)s took a median of 130 days from receipt to decision, against 53 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 4 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Companion Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2020

2016: 12018: 12020: 3
2016high 3 (2020) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2025

2022: 12025: 1
2016high 1 (2022) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Companion Medical, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Companion Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • NDCCalculator, Drug Dose4decisions
  • FMFSyringe, Piston1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 130 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 53 days; 3 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K160629InPenCompanion Medical, Inc. · 20165cite it
  • K190487InPen Dose CalculatorCompanion Medical, Inc. · 20203cite it
  • K181327InPen Dose CalculatorCompanion Medical, Inc. · 20181cites it
  • K201337InPen SystemCompanion Medical, Inc. · 20201cites it

What has FDA decided for it lately?

  • K201337InPen SystemCompanion Medical, Inc. · 20202 recalls
  • K190487InPen Dose CalculatorCompanion Medical, Inc. · 20201 recall
  • K192841InPen SystemCompanion Medical, Inc. · 20201 recall
  • K181327InPen Dose CalculatorCompanion Medical, Inc. · 2018
  • K160629InPenCompanion Medical, Inc. · 20161 recall

All 5 as Companion Medical, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K160629InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA…Mar 4, 2025Class II
  • K201337InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA…Nov 8, 2022Class II

Other applicant names beginning “Companion”

FDA records each applicant name separately; these may or may not be the same firm.

Companion Spine France 4Companion Products Intl. 2