Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FME · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
56 daysmedian FDA review time
79 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K880385 | KIMBERLY-CLARK PROFESSIONAL JACKET | Kimberly-Clark Corp. | 1988-02-19 | 22 | 0 |
| K811915 | MONITOR/VITAL SIGNS TRAY | American Hospital Supply Corp. | 1981-07-28 | 27 | 0 |
| K770476 | EXAM GOWN | General Medical Co. | 1977-05-06 | 56 | 0 |
| K760954 | CROWNTEX EXAM. CAPE & GOWN | Graham Manufacturing Co. | 1976-12-30 | 58 | 0 |
| K760360 | SHIRT, MITTEN CUFF INFANT | Precept, Inc. | 1976-10-20 | 79 | 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