Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Penn Medical Devices, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
63 daysmedian FDA review time
100 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K873949 | RORERTAZZI NASOPHARYNGEAL AIRWAY | Penn Medical Devices, Inc. | 1987-10-20 | 22 | 0 |
| K873177 | DEVINE (SUPRAPUBIC SOUND AND GUIDE) | Penn Medical Devices, Inc. | 1987-10-14 | 63 | 0 |
| K873176 | HUFFMAN BIOPSY UNIT | Penn Medical Devices, Inc. | 1987-10-14 | 63 | 0 |
| K873178 | URETERAL BULB DILATORS | Penn Medical Devices, Inc. | 1987-09-30 | 49 | 0 |
| K871667 | URETERAL STENT | Penn Medical Devices, Inc. | 1987-06-10 | 43 | 0 |
| K870508 | GASTROINTESTINAL TUBE | Penn Medical Devices, Inc. | 1987-05-11 | 95 | 0 |
| K862729 | PENN 3-RING HANDLE | Penn Medical Devices, Inc. | 1986-10-24 | 98 | 0 |
| K862107 | PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR | Penn Medical Devices, Inc. | 1986-09-11 | 100 | 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