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

HHI — Predicate Candidate Screening

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

61 daysmedian FDA review time

107 days90th percentile

24clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K171440	Berkeley VC-10 Vacuum Curettage System	Gyrus Acmi	2017-09-29	136	1
K030935	BERKELEY V-10 VACUUM CURETTAGE SYSTEM	Acmi Corporation	2003-06-23	90	0
K983181	CYTOPREP	Cytoprep Inc. Est.	1998-11-16	66	0
K931205	MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER	Baxter Healthcare Corp	1994-03-15	371	0
K904160	CYTOSMEAR BRUSH	Brooke Intl.	1990-11-02	52	0
K900641	CANNULA, SUCTION UTERINE	Williams Specialty Products, Inc.	1990-03-30	49	0
K900642	SWIVEL ADAPTER	Williams Specialty Products, Inc.	1990-03-19	38	0
K880734	SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS	Personal Products Co.	1988-04-25	61	0
K873552	CANNULA AND GENERAL PURPOSE ASPIRATOR	Cosmedtech, Inc.	1987-11-25	107	0
K870574	COSMEDTECH GENERAL ASPIRATOR	Cosmedtech, Inc.	1987-03-05	23	0
K870560	COSMEDTECH CANNULA	Cosmedtech, Inc.	1987-03-04	22	0
K862476	LS3000 CANNULA UTERINE SUCTION	Engineering, Inc.	1986-07-18	18	0
K850312	GYNASPYR VACUUM CURETTAGE UNIT	Roseburg SA	1985-02-28	34	0
K841631	MODEL 3014 SUCTION UNIT	Forma Scientific, Inc.	1984-07-03	74	0
K840382	VACUUM ASPIRATION CATHETER	Intl. Medical Technologies, Inc.	1984-04-30	91	0
K840383	MENSTRUAL ASPIRATION KIT	Intl. Medical Technologies, Inc.	1984-04-30	91	0
K840381	TAPERED CERVICAL DILATOR	Intl. Medical Technologies, Inc.	1984-04-30	91	0
K840384	DIAGNOSTIC DILATATION & MENSTRUAL KIT	Intl. Medical Technologies, Inc.	1984-04-30	91	0
K840952	MEDEVICE V-80 VACUUM PUMP	Berkeley Medevices	1984-03-30	25	0
K831112	EPCOM VCU-1 VACUUM SYSTEM & CURETTE	Epcom Medical Systems, Inc.	1983-06-30	86	0
K813282	SYNEVAC VACUUM CURETTAGE SYSTEMS	Synemed, Inc.	1981-12-14	27	0
K802360	UTERINE VACUM ASPIRATING CURRETTE	American Hospital Supply Corp.	1980-10-31	35	0
K800833	VABRA ASPIRATOR	Cooper Medical Devices Corp.	1980-05-14	30	0
K780387	VABRA ABORTION UNIT	Cooper Laboratories	1978-04-12	33	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