Prytime Medical Devices, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Prytime Medical Devices, Inc.” (first 2017, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time under this name: 54 days. Since 2017 the median was 54 days, against 110 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 |
|---|---|---|
| 2017 | 2 | 54 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 64 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 269 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Prytime Medical Devices, Inc. took a median 54 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 110 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MJN | Catheter, Intravascular Occluding, Temporary | 5 | 5 |
Review panels
- Cardiovascular (5)
Most recent Prytime Medical Devices, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243795 | pREBOA-PRO Catheter | MJN | 2025-09-05 | 269 |
| K200459 | pREBOA-PRO Catheter | MJN | 2020-06-03 | 99 |
| K193440 | ER-REBOA PLUS Catheter | MJN | 2020-01-09 | 29 |
| K172790 | ER-REBOA Catheter | MJN | 2017-11-08 | 54 |
| K170411 | ER-REBOA Catheter | MJN | 2017-04-04 | 53 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2020-12-14.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Prytime Medical Devices, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Prytime Medical Devices, Inc.” (first 2017, latest 2025), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Prytime Medical Devices, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Prytime Medical Devices, Inc. is 54 days. Since 2017: 54 days, versus 110 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Prytime Medical Devices, Inc.?
The most frequent FDA product codes under this applicant name are MJN (Catheter, Intravascular Occluding, Temporary, 5).
Next steps
- See all 5 Prytime Medical Devices, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MJN, Prytime Medical Devices, 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.