Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
U.S. Mfg. & Management, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
37 daysmedian FDA review time
69 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K920860 | CONTROLLED PASSIVE MOTION MACHINE | U.S. Mfg. & Management, Inc. | 1992-04-02 | 37 | 0 |
| K874436 | FLUID SAMPLING PACK | U.S. Mfg. & Management, Inc. | 1988-01-05 | 69 | 0 |
| K862335 | MODIFIED I.V. START, RE-START, PEDI AND GERI-KIT | U.S. Mfg. & Management, Inc. | 1986-07-24 | 35 | 0 |
| K853242 | I.V. START KIT, I.V. RESTART KIT, PEDI-KIT,GERI-KI | U.S. Mfg. & Management, Inc. | 1985-08-30 | 29 | 0 |
| K842999 | VENI-SHIELD | U.S. Mfg. & Management, Inc. | 1984-09-24 | 56 | 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