Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pharmaseal Laboratories — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
22 daysmedian FDA review time
124 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K800737 | DEBRISAN (DEXTRANOMER) PASTE | Pharmaseal Laboratories | 1980-08-04 | 124 | 0 |
| K801146 | SAMPLING KIT | Pharmaseal Laboratories | 1980-06-04 | 22 | 0 |
| K800874 | PELVIC EXAM TRAY | Pharmaseal Laboratories | 1980-05-08 | 21 | 0 |
| K800362 | FLUID DISPENSING SYSTEM | Pharmaseal Laboratories | 1980-03-12 | 21 | 0 |
| K760469 | CLEANSING AGENT, NEW WOUND (DEBRISSU) | Pharmaseal Laboratories | 1976-12-16 | 119 | 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