Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
W.E. Leder Enterprises, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
101 daysmedian FDA review time
143 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K831877 | ARF 850 E | W.E. Leder Enterprises, Inc. | 1983-11-03 | 143 | 0 |
| K831878 | CARDIO-SCOPE MINI MONITOR | W.E. Leder Enterprises, Inc. | 1983-09-29 | 108 | 0 |
| K831981 | LARYNGESCOPE | W.E. Leder Enterprises, Inc. | 1983-09-29 | 101 | 0 |
| K830159 | ANESTHESIA APPARATUS PH-35 | W.E. Leder Enterprises, Inc. | 1983-03-09 | 55 | 0 |
| K830161 | ANESTHESIA APATATUS #D-25 | W.E. Leder Enterprises, Inc. | 1983-03-09 | 55 | 0 |
| K830160 | ANESTHESIA APPARATUS #FO 20S | W.E. Leder Enterprises, Inc. | 1983-03-09 | 55 | 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