Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FYB · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
44 daysmedian FDA review time
126 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K911921 | DISPOSABLE ISOLATION GOWN | Liaoning-Usa Corp. | 1991-05-13 | 13 | 0 |
| K891820 | DISPOSABLE MEDICAL GOWNS | Bioshield, Inc. | 1989-07-24 | 126 | 0 |
| K891053 | DENTAL BIB | Dispomed, Inc. | 1989-04-12 | 44 | 0 |
| K803171 | PROCEDURE & RECOVERY PATIENT SUIT | Alba Health Care | 1981-03-04 | 79 | 0 |
| K801570 | SHIELD DISP. PATIENTS PONCHO GOWNS | American Convertors Div., American Pharmaseal | 1980-07-28 | 20 | 0 |
| K771929 | PEDIATRICS GOWN | Convertors | 1977-11-16 | 33 | 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