Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
INF · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
34 daysmedian FDA review time
164 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K924441 | U.S. MEDICAL PS-6000 WHEELCHAIR SCALE | U.S. Medical Corp. | 1993-02-12 | 164 | 0 |
| K910055 | ACME MODEL 8500 WHEELCHAIR SCALE | Acme Medical Scale Co. | 1991-01-14 | 7 | 0 |
| K884908 | ULTRAFLOTATION MEDICAL WHEELCHAIR | Medical Flotation Systems, Inc. | 1988-12-27 | 34 | 0 |
| K871391 | AMIGO-A288310 (SCOOTER, COMMUTER CART, 3-WHEELED) | Amigo Sales, Inc. | 1987-05-06 | 29 | 0 |
| K760327 | WHEEL'N WEIGH | Acme Medical Scale Co. | 1976-10-20 | 85 | 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