Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
U.S. Medical Corp. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
280 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K934677 | U. S. MEDICAL PS-3500 WARMER/INCUBATOR SCALE | U.S. Medical Corp. | 1994-07-05 | 280 | 0 |
| K924440 | U.S. MEDICAL PS-7000 DIALYSIS SCALE | U.S. Medical Corp. | 1993-05-26 | 267 | 0 |
| K924441 | U.S. MEDICAL PS-6000 WHEELCHAIR SCALE | U.S. Medical Corp. | 1993-02-12 | 164 | 0 |
| K910582 | U.S. MEDICAL PS-2000 PEDIATRIC SCALE | U.S. Medical Corp. | 1991-03-21 | 38 | 0 |
| K910581 | U.S. MEDICAL PS-1000 PEDIATRIC SCALE | U.S. Medical Corp. | 1991-03-21 | 38 | 0 |
| K910583 | U.S. MEDICAL PS-3000 NEONATAL SCALE | U.S. Medical Corp. | 1991-03-21 | 38 | 0 |
| K896633 | AUTO-CUFF(TM) | U.S. Medical Corp. | 1990-02-01 | 71 | 0 |
| K801053 | PULSED GALVANIC STIMULATOR, 450-DYNAMAX | U.S. Medical Corp. | 1980-06-04 | 30 | 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