Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pa Medical Corp. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
64 daysmedian FDA review time
68 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K910903 | INFLATE-A-CUFF #7014 | Pa Medical Corp. | 1991-05-08 | 64 | 0 |
| K871449 | ONCOLOGY SPT SYS #MS-C10 MEDICATION RESERVOIR BAG | Pa Medical Corp. | 1987-06-17 | 65 | 0 |
| K860084 | PRESSURE INFUSOR #1900 | Pa Medical Corp. | 1986-03-18 | 68 | 0 |
| K854595 | P.A. MEDICAL VAGINAL IRRIGATION SET #1130 | Pa Medical Corp. | 1986-01-13 | 56 | 0 |
| K853309 | P.A. ENTERAL FEEDING BAG 1100 | Pa Medical Corp. | 1985-08-27 | 20 | 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