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

JQC — Predicate Candidate Screening

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

40 daysmedian FDA review time

90 days90th percentile

38clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K183205	PureBMC SupraPhysiologic Concentrating System 30 mL System,	Emcyte Corporation	2019-05-30	192	0
K103340	SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYS	Harvest Technologies, Corp.	2010-12-06	21	0
K081345	AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-51	Thermogenesis Corp.	2008-07-10	57	0
K071934	MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATI	Biomet Manufacturing Corp	2007-10-11	90	1
K070666	GENESISCS COMPONENT CONCENTRATING SYSTEM	Perfusion Partners & Assoc., Inc.	2007-06-20	100	0
K052925	SMARTPREP2 CENTRIFUGE SYSTEM	Harvest Technologies, Corp.	2006-01-04	78	0
K042473	COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM	Cobe Cardiovascular, Inc.	2004-11-19	67	0
K024080	SECQUIRE CELL SEPARATOR	Perfusion Partners & Assoc., Inc.	2003-07-02	204	0
K030555	GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A	Biomet, Inc.	2003-04-11	49	0
K030340	AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129)	Cytomedix	2003-04-11	70	0
K021902	MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTO	Medtronic Vascular	2002-08-12	63	0
K994148	3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM	Implant Innovations, Inc.	2000-02-01	55	0
K991430	SMARTPREP CENTRIFUGE SYSTEM	Harvest Technologies, LLC	1999-05-28	32	0
K944738	SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME B	Ducker CL	1994-10-19	23	0
K881254	STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01	Norfolk Scientific, Inc.	1988-04-05	13	0
K864974	GENERAL PURPOSE CENTRIFUGE	Norfolk Scientific, Inc.	1987-01-09	21	0
K861146	MODEL K110SX CENTRIFUGE	Jouan S.A.	1986-05-05	40	0
K860747	DU PONT SORVALL CENTRIFUGES (RAPIDSPIN R)	E.I. Dupont DE Nemours & Co., Inc.	1986-04-14	46	0
K860172	QWIKSPIN (TM)	Norfolk Scientific, Inc.	1986-02-11	25	0
K850485	ROTOR SYSTEMS A/S-400 & LA/S-400	E.I. Dupont DE Nemours & Co., Inc.	1985-03-12	33	0
K843434	ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC.	Iso-Data, Inc.	1984-10-05	31	0
K843087	UNIVERSAL 2 S CENTRIFUGE	Boehringer Mannheim Corp.	1984-08-29	23	0
K843088	EBA 3 S CENTRIFUGE	Boehringer Mannheim Corp.	1984-08-29	23	0
K840768	CENTRIFUGES	Heraeus-Christ GmbH	1984-05-07	74	0
K831942	LKB 2164 MACRO-SPIN R CENTRIFUGE	Lkb Instruments, Inc.	1983-07-29	43	0
K831947	LKB 2160 MIDISPIN CENTRIFUGE	Lkb Instruments, Inc.	1983-07-29	43	0
K831948	LKB 2161 MIDISPIN R CENTRIFUGE	Lkb Instruments, Inc.	1983-07-29	43	0
K822715	PLATELET CENTRIFUGE	Biodynamics Corp.	1982-09-30	23	0
K822422	BASIC CENTRIFUGE	Biodynamics Corp.	1982-09-02	21	0
K821756	IEC CENTRA 4 CENTRIFUGE	International Equipment Co.	1982-06-25	10	0
K813524	CENTIDISC	Bel-Art Products	1981-12-31	15	0
K812505	PALL ULTIPOR VACUUM LINE BACTERIA FITLER	Pall Biomedical Products Co.	1981-09-16	15	0
K810833	SORVALL RT6000 REFRIGERATED TABLETOP	E.I. Dupont DE Nemours & Co., Inc.	1981-04-08	14	0
K802210	CONICAL TIPPED CENTRIFUGE TUBE 15M	Scientific Specialties, Inc.	1980-09-26	14	0
K800381	REFRIG. CENTRIFUGE (DRUCKER MODEL)	Coulter Electronics, Inc.	1980-03-19	26	0
K782124	IEC CENTRA-7 CENTRIFUGE MODEL 2362	Damon Corp.	1979-02-26	61	0
K761013	SPINETTE CENTRIFUGE	Damon Corp.	1976-11-16	7	0
K760467	ROTATOR, FIXED SPEED	Lederle Laboratories	1976-10-29	72	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