Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

HFI — Predicate Candidate Screening

8 FDA 510(k) clearances under this product code; the 50 most recent screened below.

507 daysmedian FDA review time

560 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K151567	ENDOPLUS hand-held laparoscopic instruments	Endoplus	2015-12-23	196
K925960	FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE	Zinnanti Surgical Instruments, Inc.	1994-06-07	560
K925957	SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE	Zinnanti Surgical Instruments, Inc.	1994-06-07	560
K936026	COOK LAPAROSCOPIC MINI RETRACTOR SET	Cook Urological, Inc.	1994-03-11	84
K925114	LAPAROSCOPIC INSTRUMENTS	Endo Technic Corp.	1994-02-28	507
K924148	DIAMOND-SHARP(R) TROCARS	Snowden-Pencer	1994-02-28	559
K930571	REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING	Numed Technologies, Inc.	1994-02-01	362
K844053	CANON 60 DEGREE FUNDUS CAMERA CF-60S	Canon USA, Inc.	1984-12-19	62

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