Companion Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Companion Medical, Inc.” (first 2016, latest 2020), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 130 days. Since 2017 the median was 90 days, against 162 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 141 |
| 2017 | 0 | — |
| 2018 | 1 | 49 |
| 2019 | 0 | — |
| 2020 | 3 | 130 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Companion Medical, Inc. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 162 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NDC | Calculator, Drug Dose | 4 | 4 |
| FMF | Syringe, Piston | 1 | 1 |
Review panels
Most recent Companion Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201337 | InPen System | NDC | 2020-06-18 | 29 |
| K190487 | InPen Dose Calculator | NDC | 2020-02-18 | 355 |
| K192841 | InPen System | NDC | 2020-02-10 | 130 |
| K181327 | InPen Dose Calculator | NDC | 2018-07-06 | 49 |
| K160629 | InPen | FMF | 2016-07-26 | 141 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2022-11-08.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Companion Products Intl. (2 510(k)s)
- Companion Spine France (1 510(k)s)
- Companion Spine France Sas (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Companion Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Companion Medical, Inc.” (first 2016, latest 2020), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Companion Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Companion Medical, Inc. is 130 days. Since 2017: 90 days, versus 162 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Companion Medical, Inc.?
The most frequent FDA product codes under this applicant name are NDC (Calculator, Drug Dose, 4); FMF (Syringe, Piston, 1).
Next steps
- See all 5 Companion Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NDC, Companion Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.