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

EQJ — Predicate Candidate Screening

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

50 daysmedian FDA review time

208 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days
K161514	Precision Thin Reciprocating Blade, 0.010in.	Stryker Corporation	2017-01-17	229
K041985	XPS CURVED BUR	Medtronic Xomed, Inc.	2004-08-12	20
K974232	ESSENTIAL SHAVER SYSTEM	Gyrus Ent LLC	1998-01-12	61
K960853	ACE SYSTEM	Xomed, Inc.	1996-04-03	33
K955704	TREBAY MICRODEBRIDER SYSTEM	Trebay Medical Corp.	1996-01-30	46
K955294	SOF - ABRASION BUR	Trebay Medical Corp.	1995-12-22	35
K954912	TREBAY IRRIGATED CUTTER BLADE (MODIFICATION)	Trebay Medical Corp.	1995-12-06	44
K953370	KARL STORZ ENT SHAVER	KARL STORZ Endoscopy-America, Inc.	1995-09-06	50
K950337	KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL	KARL STORZ Endoscopy-America, Inc.	1995-08-23	208
K952609	REDI DRILL DRILL SYSTEM	Trebay Medical Corp.	1995-07-31	54
K953096	ESSENTIAL SHAVER SYSTEM	Smith & Nephew Richards, Inc.	1995-07-28	25
K946332	KARL STORZ MICRO-INSTRUMENT FOR COCHLEAR IMPLANTATION	KARL STORZ Endoscopy-America, Inc.	1995-06-05	158
K951526	TREBAY IRRGATED CUTTER BLADE	Trebay Medical Corp.	1995-05-12	39
K935584	MEDNEXT BUR	Mednext, Inc.	1994-02-22	96
K895738	MICROMEDICS EAR, NOSE AND THROAT BURS	Micromedics, Inc.	1989-12-19	84
K893499	CMS FAST CUT, CMS DIAMOND AND CMS WIRE PASS	Cmsi	1989-11-16	196
K802503	MICRO-SUGICAL POWER INSTRUMENT SYSTEM	Spire Medical, Inc.	1980-10-31	14
K792028	OTOTOME BUR	American Sterilizer Co.	1979-10-26	17

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