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

HCI — Predicate Candidate Screening

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

87 daysmedian FDA review time

328 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K221524	Sugita AVM Microclip Applier	Mizuho America, Inc.	2022-06-24	29	0
K211572	Aesculap Slim Clip Applier	Aesculap, Inc.	2021-12-13	206	0
K180914	Aesculap Slim Clip Applier	Aesculap, Inc.	2018-04-17	8	0
K173271	Aesculap Slim Clip Applier Forceps	Aesculap, Inc.	2017-11-10	29	0
K010910	MEDICON YASARGIL CLIP APPLYING FORCEPS	Medicon EG	2001-08-01	128	0
K994191	SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-37	Nmt Medical, Inc.	2000-02-08	57	0
K984109	AESCULAP AXIAL CLIP APPLIER	Aesculap, Inc.	1999-02-12	87	0
K982379	SUNDT SLIM-LINE ANEURYSM CLIP APPLIER	Johnson & Johnson Professionals, Inc.	1998-12-18	163	0
K954658	PERNECZKY CLIP APPLIER/REMOVER	Von Zeppelin GmbH	1996-10-08	364	0
K940970	YASARGIL, CASPAR, VARIO CLIP APPLIERS	Aesculap, Inc.	1995-01-24	328	2
K902544	SUNDT AVM MICRO CLIP	Codman & Shurtleff, Inc.	1990-09-20	106	0
K881912	SANO CLIP APPLIERS & REMOVERS	Downs Surgical , Ltd.	1988-06-06	28	0
K881911	NEW SIZES SUGITA CLIPS	Downs Surgical , Ltd.	1988-06-06	28	0
K833651	CLIP APPLYING FORCEPS	Advanced Biosearch Assn.	1983-11-29	41	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