Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DWZ — Predicate Candidate Screening
23 FDA 510(k) clearances under this product code; the 50 most recent screened below.
84 daysmedian FDA review time
191 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252722 | Biopsy Forceps | Fehling Instruments GmbH | 2025-09-30 | 33 | 0 |
| K170726 | Biopsy Forceps | Fehling Instruments GmbH & Co. KG | 2017-06-02 | 85 | 0 |
| K072051 | NOVATOME, MODEL: SU101-50 | Scholten Surgical Instruments, Inc. | 2007-10-03 | 69 | 0 |
| K010473 | SPARROWHAWK DISPOSABLE | Atc Technologies, Inc. | 2001-06-06 | 106 | 0 |
| K000409 | MODIFICATION TO T-REX BIOPSY FORCEPS | Boston Scientific Corp | 2000-02-28 | 20 | 0 |
| K991486 | ULTRA-CBX | Medcanica, Inc. | 1999-11-05 | 191 | 0 |
| K973818 | T-REX BIOPSY FORCEPS | Boston Scientific Corp | 1997-12-16 | 70 | 0 |
| K974175 | HEARTPORT ENDOAORTIC CLAMP CATHETER | Heartport, Inc. | 1997-12-16 | 40 | 2 |
| K951447 | DYNABITE CARDIOVASCULAR BIOPSY FORCEPS | Portlyn Corp. | 1995-07-27 | 120 | 0 |
| K933235 | CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIF | Cordis Corp. | 1994-01-06 | 232 | 0 |
| K932788 | CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLE | Cordis Corp. | 1993-09-01 | 84 | 0 |
| K921401 | BIOPSY FORCEPS | Annex Medical, Inc. | 1992-10-21 | 211 | 0 |
| K920289 | CORDIS BIPAL 7 BIOPSY FORCEPS | Cordis Corp. | 1992-03-30 | 68 | 0 |
| K914567 | CORDIS BIPAL BIOPSY FORCEPS | Cordis Corp. | 1991-12-18 | 64 | 0 |
| K910840 | VASCULAR BIOPSY FORCEPS | Vascular Products, Inc. | 1991-07-15 | 138 | 0 |
| K901300 | BIOPSY FORCEPS | Portlyn Corp. | 1990-06-29 | 101 | 0 |
| K895098 | BIOPSY FORCEPS | Annex Medical, Inc. | 1989-10-30 | 76 | 0 |
| K890453 | REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES | Dlp, Inc. | 1989-03-31 | 60 | 0 |
| K883723 | FLEXIBLE MYOCARDIAL BIOPSY FORCEPS | Cook, Inc. | 1988-12-05 | 96 | 0 |
| K882383 | MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES | CIVCO Medical Instruments Co., Inc. | 1988-11-28 | 172 | 0 |
| K881412 | MYOCARD BIOPSY FORCEP | Fehling Medizintechnik GmbH | 1988-09-08 | 157 | 0 |
| K870186 | ENDOMYOCARDIAL BIOPSY DEVICE | Mansfield Scientific, Inc. | 1987-02-20 | 35 | 0 |
| K810849 | CORDIS BIOPSY FORCEPS | Cordis Corp. | 1981-04-17 | 18 | 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