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

HAE — Predicate Candidate Screening

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

149 daysmedian FDA review time

284 days90th percentile

36clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K242759	Geister K-Rex rongeurs	Geister Medizin Technik GmbH	2025-06-06	267	0
K223596	SQ.line KERRISON	Aesculap, Inc.	2023-06-29	209	0
K230256	Rebellion, Phantom Multi-Bite Kerrison Rongeur	Morpheus AG	2023-03-03	31	0
K221818	Rebellion; Phantom Multi-Bite Kerrison Rongeur	Morpheus AG	2022-10-07	106	0
K210741	KLS Martin Neuro Rongeurs	KLS-Martin L.P.	2022-06-03	448	0
K200768	Rebellion, Phantom Multi-Bite Kerrison Rongeur	Morpheus AG	2021-05-04	405	0
K200387	Ace Medical Surgical Instruments	Ace Medical	2020-07-21	154	0
K200383	Wiggins Medical Surgical Instruments	Wiggins Medical	2020-07-21	154	0
K180949	Steribite	Rjr Surgical, Inc.	2018-11-08	211	0
K161744	Symmetry Sharp Kerrison Rongeur	Symmetry Surgical, Inc.	2016-09-07	75	0
K153243	Fehling-Punches	Fehling Instruments GmbH & Co. KG	2016-08-04	269	0
K152734	Kerrison Rongeurs	Vitalitec Medizintechnik GmbH	2016-06-18	270	0
K150468	Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs	K2 Medical GmbH & Co. KG	2016-02-29	371	0
K150428	Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles	Integra Lifesciences Corp.	2015-04-16	56	0
K131851	OSTEOMED NEURO RONGEUR	Osteomed	2013-12-06	168	0
K130541	SYMMETRY KERRISON DISPOSABLE TIP RONGEURS	Symmetry Surgical	2013-08-05	157	0
K113073	IO-TOME DEVICE	Baxano, Inc.	2012-07-27	284	0
K113533	NEURO CHECK DEVICE WITH IO-FLEX WIRE	Baxano, Inc.	2012-04-11	133	0
K100958	MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES	Baxano, Inc.	2010-07-23	107	0
K092227	JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND -	Integra Lifesciences Corp.	2010-02-17	209	0
K081651	INSTRUMED RONGEUR	Instrumed International, Inc.	2008-08-08	57	0
K080494	BAXANO ULTRA LOW PROFILE RONGEUR	Baxano, Inc.	2008-03-04	11	0
K063231	MICROBLADE SHAVER AND ACCESSORIES	Baxano, Inc.	2007-04-16	173	0
K062711	ULTRA LOW PROFILE RONGEUR	Baxano, Inc.	2007-03-07	177	0
K023868	DAN KERRISON RONGEURS, MODELS K1 + BILLY 1	Dannoritzer Medical Instruments	2003-02-07	79	0
K954699	BRAY RONGEUR	Johnson & Johnson Professionals, Inc.	1995-12-06	55	0
K943583	KERRISON RONGEURS	Enterprise Medical Corp.	1995-02-21	214	0
K943635	ULTRA-LINE RONGEUR	V. Mueller Neuro/Spine	1994-12-07	133	0
K943116	AUTO SUTURE KERRISON SPINAL RONGEUR	United States Surgical, A Division of Tyco Healthc	1994-07-27	30	1
K933978	NEDBOND EJECTOR KERRISON RONGEUR	Redmond Neurotechnologies Corp.	1994-01-12	149	0
K903151	INTERVERTEBRAL DISC RONGEUR	Von Zeppelin GmbH	1990-12-11	146	0
K903401	SPECIAL RONGEUR	Sur-Med Instruments, Inc.	1990-08-10	10	0
K901313	INSTRUMENTS FOR NEUROLOGICAL SURGERY	Von Zeppelin GmbH	1990-07-23	125	0
K901372	LAMINECTOMY RONGEUR	Zeppelin GmbH	1990-06-28	98	0
K892535	NEUROLOGICAL RONGEURS - VARIOUS TYPES	Zinnanti Surgical Instruments, Inc.	1989-05-11	30	0
K875043	RONGEUR (NEUROSURGICAL INSTRUMENTS)	Solway, Inc.	1988-01-22	51	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