Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
A.Stein - Regulatory Affairs Consulting — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
155 daysmedian FDA review time
880 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972383 | EASY-JET DEVICE | A.Stein - Regulatory Affairs Consulting | 1999-11-23 | 880 | 0 |
| K973592 | WALKCARE P200 SYSTEM | A.Stein - Regulatory Affairs Consulting | 1999-05-20 | 605 | 0 |
| K982754 | EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P | A.Stein - Regulatory Affairs Consulting | 1999-01-08 | 155 | 0 |
| K973590 | HEMORRELIEF DEVICE | A.Stein - Regulatory Affairs Consulting | 1998-02-05 | 136 | 0 |
| K973148 | MACOM | A.Stein - Regulatory Affairs Consulting | 1997-11-20 | 90 | 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