Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
BZS — Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K935146 | DISPOSABLE STETHOSCOPE HEAD COVER | Modern Medical Devices, Inc. | 1994-07-11 | 256 | 0 |
| K930118 | STETSKINS | Nova Diversified Concepts | 1993-03-26 | 74 | 0 |
| K801050 | SUPRA SCOPE | Warner-Lambert Co. | 1980-05-14 | 9 | 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