Atlas FDA

JQC

38 FDA 510(k) clearances · Product code

40 daysmedian time to decision
90 days90th percentile
38clearances measured

FDA profile

Official device name
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2050
Medical specialty
Clinical Chemistry
Flags
GMP exempt
Adverse events (MAUDE)
2012: 18 · 2013: 26 · 2014: 112 · 2015: 130 · 2016: 70 · 2017: 31
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System (K183205)Emcyte Corporation2019-05-30
SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM (K103340)Harvest Technologies, Corp.2010-12-06
AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY) (K081345)Thermogenesis Corp.2008-07-10
MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT (K071934)Biomet Manufacturing Corp2007-10-11
GENESISCS COMPONENT CONCENTRATING SYSTEM (K070666)Perfusion Partners & Assoc., Inc.2007-06-20
SMARTPREP2 CENTRIFUGE SYSTEM (K052925)Harvest Technologies, Corp.2006-01-04
COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM (K042473)Cobe Cardiovascular, Inc.2004-11-19
SECQUIRE CELL SEPARATOR (K024080)Perfusion Partners & Assoc., Inc.2003-07-02
GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A (K030555)Biomet, Inc.2003-04-11
AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129) (K030340)Cytomedix2003-04-11
MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300 (K021902)Medtronic Vascular2002-08-12
3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM (K994148)Implant Innovations, Inc.2000-02-01
SMARTPREP CENTRIFUGE SYSTEM (K991430)Harvest Technologies, LLC1999-05-28
SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME BASE CENTRIFUGE (K944738)Ducker CL1994-10-19
STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01 (K881254)Norfolk Scientific, Inc.1988-04-05
GENERAL PURPOSE CENTRIFUGE (K864974)Norfolk Scientific, Inc.1987-01-09
MODEL K110SX CENTRIFUGE (K861146)Jouan S.A.1986-05-05
DU PONT SORVALL CENTRIFUGES (RAPIDSPIN R) (K860747)E.I. Dupont DE Nemours & Co., Inc.1986-04-14
QWIKSPIN (TM) (K860172)Norfolk Scientific, Inc.1986-02-11
ROTOR SYSTEMS A/S-400 & LA/S-400 (K850485)E.I. Dupont DE Nemours & Co., Inc.1985-03-12
ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC. (K843434)Iso-Data, Inc.1984-10-05
UNIVERSAL 2 S CENTRIFUGE (K843087)Boehringer Mannheim Corp.1984-08-29
EBA 3 S CENTRIFUGE (K843088)Boehringer Mannheim Corp.1984-08-29
CENTRIFUGES (K840768)Heraeus-Christ GmbH1984-05-07
LKB 2164 MACRO-SPIN R CENTRIFUGE (K831942)Lkb Instruments, Inc.1983-07-29
LKB 2160 MIDISPIN CENTRIFUGE (K831947)Lkb Instruments, Inc.1983-07-29
LKB 2161 MIDISPIN R CENTRIFUGE (K831948)Lkb Instruments, Inc.1983-07-29
PLATELET CENTRIFUGE (K822715)Biodynamics Corp.1982-09-30
BASIC CENTRIFUGE (K822422)Biodynamics Corp.1982-09-02
IEC CENTRA 4 CENTRIFUGE (K821756)International Equipment Co.1982-06-25
CENTIDISC (K813524)Bel-Art Products1981-12-31
PALL ULTIPOR VACUUM LINE BACTERIA FITLER (K812505)Pall Biomedical Products Co.1981-09-16
SORVALL RT6000 REFRIGERATED TABLETOP (K810833)E.I. Dupont DE Nemours & Co., Inc.1981-04-08
CONICAL TIPPED CENTRIFUGE TUBE 15M (K802210)Scientific Specialties, Inc.1980-09-26
REFRIG. CENTRIFUGE (DRUCKER MODEL) (K800381)Coulter Electronics, Inc.1980-03-19
IEC CENTRA-7 CENTRIFUGE MODEL 2362 (K782124)Damon Corp.1979-02-26
SPINETTE CENTRIFUGE (K761013)Damon Corp.1976-11-16
ROTATOR, FIXED SPEED (K760467)Lederle Laboratories1976-10-29

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Every clearance here is in the API, with alerts when new ones post.