Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
NLU · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050136 | REPROCESSED HOT BIOPSY FORCEPS | Sterilmed, Inc. | 2005-07-20 | 180 | 1 |
| K033593 | REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS | Clearmedical, Inc. | 2003-11-20 | 7 | 0 |
| K024011 | SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPI | Surgical Instruments Service and Savings, Inc. | 2002-12-19 | 15 | 0 |
| K011800 | VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS | Vanguard Medical Concepts, Inc. | 2001-09-27 | 111 | 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