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

HEE — Predicate Candidate Screening

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

86 daysmedian FDA review time

210 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K052365	CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE	Rocket Medical Plc	2005-10-17	49	0
K021224	ENDOCERVICAL BLOCK NEEDLE	Wallach Surgical Devices, Inc.	2002-07-12	86	0
K000117	AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE	Avid Medical, Inc.	2000-04-13	90	0
K983897	CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE	Ri Mos. S.R.L.	1999-02-01	90	0
K980238	GYNEX EXTENDED REACH NEEDLE	Gynex Corp.	1998-08-21	210	0
K973671	ENDOCERVICAL BLOCK NEEDLE	A & A Medical, Inc.	1997-11-26	61	0
K954718	ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE	Ellman Intl., Inc.	1996-02-29	139	0
K910253	LEEP REDIKIT	CooperSurgical, Inc.	1991-04-18	86	2
K910252	POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE	CooperSurgical, Inc.	1991-03-04	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