Atlas FDA

GIM

39 FDA 510(k) clearances · Product code

57 daysmedian time to decision
259 days90th percentile
39clearances measured

FDA profile

Official device name
Tubes, Vacuum Sample, With Anticoagulant
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1675
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2021: 55 · 2022: 42 · 2023: 33 · 2024: 316 · 2025: 652 · 2026: 275
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
BD Vacutainer® Citrate Blood Collection Tubes (K240455)Becton, Dickinson and Company2024-10-31
BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube (K230493)Becton, Dickinson and Company2023-11-27
BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes (K213670)Becton, Dickinson and Company2023-08-25
TransFix/EDTA Vacuum Blood Collection Tubes (K162723)Caltag Medsystems, Ltd.2017-06-22
CYTO-CHEX BCT (K080552)Streck2008-07-31
DS30 HCY BLOOD COLLECTION TUBES (K012152)Drew Scientific , Ltd.2001-09-18
VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) (K971449)Becton Dickinson Vacutainer Systems1997-06-17
GREINER VACUETTE BLOOD COLLECTION TUBE (K971221)Greiner America, Inc.1997-05-02
LOK-ON NEEDLE DISPOSAL SYSTEM (K951886)Becton Dickinson Vacutainer Systems1995-06-30
VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM (K945458)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-02-06
CORVAC PLASTIC BLOOD COLLECTION TUBE (K944814)Sherwood Medical Co.1994-12-19
MONOJECT BLOOD COLLECTION TUBES W/SAFETY STOPPER (K940058)Sherwood Medical Co.1994-05-02
BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT (K933939)Organon Teknika Corp.1994-02-07
VACUTAINER BRAND SAFETY-GARD NEEDLE HOLDER & NEEDLE DISPOSABLE CONTAINER SYSTEM (K933386)Bd Becton Dickinson Vacutainer Systems Preanalytic1993-10-12
MULTIDRAW SYSTEM (K922858)Cambridge Multi-Draw, Inc.1992-11-16
ANGEL WING SETS -- MODIFIED (K922468)Mbo Laboratories, Inc.1992-07-10
DIRECTDRAW SUPERSERUM (K921778)International Technidyne Corp.1992-05-28
VACUTAINER(R) BRAND SAFETY-LOK BLOOD COLLECT SET (K921636)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-04-29
ANGEL WING SAFETY BLOOD COLLECTION WITH TUBE HOLD. (K920184)Mbo Laboratories, Inc.1992-02-18
VACUTAINER KIT (K914901)Abbott Laboratories1992-01-08
CORVAC BLOOD COLLECTION TUBE (K915213)Sherwood Medical Co.1992-01-08
1400 SERIES EVIDENCE COLLECTION KIT (K896373)Transidyne General Corp.1990-02-26
QS90 SMOOTH E ARTERIAL BLOOD SAMPLER (K896514)Radiometer America, Inc.1990-01-23
ACCUFIBRIN(TM) BLOOD COLLECTION SYSTEM AF100 (K882501)Terumo Medical Corp.1988-07-18
VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE) (K861449)Exel Intl.1986-09-16
SYRINGE FOR BLOOD SAMPLING (K803182)The University of Chicago1981-01-16
PREZAPAK L ARTERIAL BLOOD SAMPLING KIT (K801015)Kimble-Terumo, Inc.1980-05-14
PRE-DENT (K791200)Fichte, Graves, and Hunt1979-08-10
J-VAC VACUUM TUBE (K771874)Jelco Laboratories1977-12-02
FILTER SAMPLER BLOOD SERUM FILTER (K771985)Clasrock1977-11-02
LIQUAEMIN SODIUM, HEPARIN SODIUM ETC. (K771305)Organon, Inc.1977-08-04
LIQUAEMIB SODIUM PRESERVATIVE, ETC. (K771304)Organon, Inc.1977-08-04
BLOOD COLLECTION TUBE, GRAY (K771053)Sherwood Medical Industries1977-06-29
BLOOD COLLECTION TUBE, RED (K771055)Sherwood Medical Industries1977-06-29
BLOOD COLLECTION TUBE, GREEN (K771056)Sherwood Medical Industries1977-06-29
BLOOD COLLECTION TUBE, BLUE (K771054)Sherwood Medical Industries1977-06-29
BLOOD COLLECTION TUBE, LAVENDER (K771052)Sherwood Medical Industries1977-06-27
VACUUM TUBES, PEDIATRIC SIZES (J-VAC) (K760019)Jelco Laboratories1976-07-20
VACUUM TUBES, STERILE (J-VAC) (K760018)Jelco Laboratories1976-07-20

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