Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Primed Medical Products, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
182 daysmedian FDA review time
397 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252964 | PRIMED Surgical and Procedure Masks | Primed Medical Products, Inc. | 2025-11-04 | 48 | 0 |
| K242208 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P60 | Primed Medical Products, Inc. | 2024-10-07 | 70 | 0 |
| K240286 | PRIMED Surgical Masks and PRIMED Procedure Masks | Primed Medical Products, Inc. | 2024-08-26 | 207 | 0 |
| K233777 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P60 | Primed Medical Products, Inc. | 2024-05-24 | 182 | 0 |
| K213427 | PRIMED Pediatric Facemask | Primed Medical Products, Inc. | 2022-11-22 | 397 | 0 |
| K160361 | PRIMAGARD Isolation Gown (AAMI PB70 Level 3) | Primed Medical Products, Inc. | 2016-11-04 | 269 | 0 |
| K092012 | PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, M | Primed Medical Products, Inc. | 2009-09-25 | 81 | 0 |
| K081633 | PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FA | Primed Medical Products, Inc. | 2008-08-11 | 61 | 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