Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

HBO — Predicate Candidate Screening

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

77 daysmedian FDA review time

139 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K253814	Raney Clips Kit	Beijing Honghugaoxiang Science and Technology Development CO	2026-07-21	235
K050044	MEDTRONIC CLIP GUN KIT	Medtronic Neurosurgery	2005-02-07	28
K033660	STORZ RANEY SCALP CLIP, MODEL 1-20-004-05	Rudolf Storz GmbH	2004-01-07	47
K012219	SCALPFIX CLIP SYSTEM	Aesculap, Inc.	2001-07-31	15
K944311	ACRA-CUT	Acra Cut, Inc.	1994-11-18	77
K905433	CODMAN DISPOSABLE SCALP CLIP APPLIER	Codman & Shurtleff, Inc.	1991-02-21	79
K896723	CLIP GUN WITH RANEY TYPE SCALP CLIPS	Omni Medical Designs	1990-03-23	114
K894778	CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER	Codman & Shurtleff, Inc.	1989-12-06	132
K890443	CASPAR SCALP CLIP, APPLIER	Aesculap Instruments Corp.	1989-06-15	139
K883963	RANEY AND LEROY-RANEY SCALP CLIP	New England Surgical Instrument Corp.	1988-10-07	17
K881265	RANEY CLIPS	Zimmer, Inc.	1988-05-31	68

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