Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Prytime Medical Devices, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
54 daysmedian FDA review time
269 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243795 | pREBOA-PRO Catheter | Prytime Medical Devices, Inc. | 2025-09-05 | 269 | 0 |
| K200459 | pREBOA-PRO Catheter | Prytime Medical Devices, Inc. | 2020-06-03 | 99 | 0 |
| K193440 | ER-REBOA PLUS Catheter | Prytime Medical Devices, Inc. | 2020-01-09 | 29 | 0 |
| K172790 | ER-REBOA Catheter | Prytime Medical Devices, Inc. | 2017-11-08 | 54 | 0 |
| K170411 | ER-REBOA Catheter | Prytime Medical Devices, Inc. | 2017-04-04 | 53 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda