Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Med USA — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
103 daysmedian FDA review time
300 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K896766 | TD-28 DISPOSABLE ELECTRODE | Med USA | 1990-03-14 | 103 | 0 |
| K862047 | COAGULATOR (8 CHANNEL) | Med USA | 1986-09-29 | 123 | 0 |
| K852492 | COAGULATOR | Med USA | 1985-08-13 | 62 | 0 |
| K850711 | INHALATION THERAPY NEBULIZER DEVICE | Med USA | 1985-06-05 | 103 | 0 |
| K841803 | A1 SYSTEME 8201/2 | Med USA | 1985-02-25 | 300 | 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