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

HHK — Predicate Candidate Screening

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

84 daysmedian FDA review time

244 days90th percentile

42clearances measured

K-number	Device	Applicant	Decided	Review days
K251882	Uterine Aspiration Set	Gcmedica Enterprise Ltd.(Wuxi)	2025-10-16	118
K240434	RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)	Li Medical Corporation , Ltd.	2024-09-25	224
K201952	CrossGlide ETS Plus	Crossbay Medical	2020-08-05	22
K192534	CrossBay Endometrial Tissue Sampler (ETS)	Crossbay Medical	2020-03-25	191
K102847	DISPOSABLE ENDOMETRIAL SUCTION CURETTE	Jiangsu Suyun Medical Materials Co., Ltd.	2011-04-14	197
K092982	THE PANPAC SUCTION CURETTE	Panpac Medical Corporation	2010-07-26	301
K051294	FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1	Femspec LLC	2005-12-21	217
K040189	ENDOMETRIAL SAMPLING SYRINGE	Rocket Medical Plc	2004-10-04	250
K021876	MAS WITH OR WITHOUT SYRINGE	Marina Medical Instruments, Inc.	2003-04-08	305
K020628	CURELLE, PREFERRED CURELLE, CUTEQ 2.5	Bioteque America, Inc.	2002-05-24	87
K001555	SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26	Sims Portex , Ltd.	2000-08-02	76
K001545	PIPET CURET	Milex Products, Inc.	2000-06-15	28
K000974	FOWLER ENDOCURETTE, MODEL CUR-XXX	Utah Medical Products, Inc.	2000-05-23	57
K000026	APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER	Apple Medical Corp.	2000-03-31	86
K992926	GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195)	Ri Mos. S.R.L.	1999-10-26	56
K991895	RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217)	Ri Mos. S.R.L.	1999-08-12	70
K990387	ENDOMETRIAL SAMPLER	U.A. Medical Products, Inc.	1999-04-20	71
K974819	SELECTCELLS(TM) MINI	Select Medical Systems, Inc.	1998-03-23	90
K960239	CPR D & C TRAY	Custom Pack Reliability	1996-05-23	128
K954097	SELECTCELLS STANDARD	Select Medical Systems, Inc.	1995-11-21	82
K952652	MEDSCAND ENDORETTE ENDOMETRIAL SAMPLER	Medscand (Usa), Inc.	1995-09-15	98
K915491	CURELLE	Bioteque Corp.	1992-11-04	334
K914220	PIONEER PRO-PUMP	Pioneer Medical, Inc.	1992-03-04	167
K914241	PIONEER PRO-PUMP DUAL CONTROL	Pioneer Medical, Inc.	1992-03-04	163
K881456	PIPELLE DE CORNIER ENDOMETRIAL SUCTION CURETTE	Laboratoire Ccd C/O Washington Regulatory Services	1988-10-14	191
K875084	CABOT MEDICAL ENDOMETRIAL SUCTION CURETTE	Cabot Medical Corp.	1988-02-08	61
K872908	ENDOMETRIAL SAMPLER	Zinnanti Surgical Instruments, Inc.	1987-10-20	88
K853216	MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4	Gyneco, Inc.	1986-04-02	244
K854415	ENDOMETRIAL PIPELLE	Unimar, Inc.	1986-03-13	129
K823080	VAKUTAGE	Weston, Copco, Inc.	1982-11-24	36
K823006	MEDEVICES ASPIRATION HOSE	Berkeley Medevices	1982-11-04	23
K822382	U.V.A.C. HANDLER SET	American Hospital Supply Corp.	1982-08-25	16
K812426	UTERINE ASPIRATION CURETTES(RIGID&FLEX)	Medi-Spec	1981-10-08	44
K803210	MENSTRUAL ASPIRATION KITS	Gynemetrics, Inc.	1981-01-28	41
K801070	SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES	Sherwood Medical Industries	1980-07-21	76
K791765	MASTERSON* ENDOMETRIAL BIOPSY KIT	Codman & Shurtleff, Inc.	1979-11-05	69
K790875	MONOJECT ENDOMETRIAL SAMPLING KIT	Sherwood Medical Co.	1979-07-30	84
K781830	BIOPSY KIT 781101, ASPIRATION	Vista Products, Inc.	1978-11-15	15
K772121	ASPIRATOR & PROBE, CYTOLOGY, ENDOMET.	Smithkline Diagnostics, Inc.	1977-11-17	7
K771149	ENDOMETRIAL ASPIRATION BIOSPY KIT 182341	C.R. Bard, Inc.	1977-07-27	30
K770674	CURETTE, UTERINE, VACUUM ASPIRATING	American Hospital Supply Corp.	1977-04-26	15
K760264	CURETTE, PROPOSED TIS-U-TRAP, METAL	Milex Products, Inc.	1976-10-06	77

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