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

FBQ — Predicate Candidate Screening

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

64 daysmedian FDA review time

133 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K012198	GIBBONS STERILE TROCAR KITS	Gibbons Surgical Corp.	2001-08-09	27
K980804	SABRE BT BLUNT0TIP SURGICAL TROCAR	Endoscopic Concepts, Inc.	1998-04-01	30
K944640	LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT	Gabris Surgical Corp.	1994-10-11	20
K944104	GABRIS LAPAROSCOPIC SURGICAL KITS	Gabris Surgical Corp.	1994-09-13	21
K942885	AUTO SUTURE MODIFIED GRIP	United States Surgical, A Division of Tyco Healthc	1994-08-22	66
K934724	AESCULAP TROCAR INSTRUMENT SET	Aesculap, Inc.	1993-12-23	83
K904638	TROCAR DISPOSABLE	L.A.S.E.R., Inc.	1991-02-21	133
K900123	AUTO SUTURE SURGIPORT SPIRAL SLEEVE	United States Surgical, A Division of Tyco Healthc	1990-04-04	85
K841716	ENDOPORT EROCAR	Endotherapeutics	1984-06-28	64

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