Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Ansley Medical Products, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
75 daysmedian FDA review time
275 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K932857 | ABDOMINAL FLUID CONTROL POUCH, 203-301-S;ETC. | Ansley Medical Products, Inc. | 1993-09-13 | 95 | 0 |
| K925290 | CATALOG NUMBER 111 (FACESHIELD) | Ansley Medical Products, Inc. | 1993-07-23 | 275 | 0 |
| K924566 | RESTRAINT, PROTECTIVE N0. 103 | Ansley Medical Products, Inc. | 1992-11-23 | 75 | 0 |
| K924567 | FOLEY CATHETER TUBE HOLDER NO. 101 | Ansley Medical Products, Inc. | 1992-11-23 | 75 | 0 |
| K924568 | TUBE, LEAD, AND CORD HOLDER NO. 102 | Ansley Medical Products, Inc. | 1992-11-23 | 75 | 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