Atlas FDA

GIO

22 FDA 510(k) clearances · Product code

41 daysmedian time to decision
60 days90th percentile
22clearances measured

FDA profile

Official device name
Tube, Collection, Capillary Blood
Device class
Class I (low risk)
Regulation
21 CFR 864.6150
Medical specialty
Hematology
Adverse events (MAUDE)
1992: 2 · 1994: 1 · 1999: 1 · 2003: 1 · 2004: 3 · 2007: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM (K972969)Innovative Medical Technologies, Inc.1997-09-22
MONOJECT SAMPLETTE SEPARATOR TUBE (K941291)Sherwood Medical Co.1994-10-27
TRU-TRAX (K894851)Humagen, Inc.1989-09-29
HEMA(PRO)TEC(TION) (K885324)Medical Products Search, Inc.1989-02-17
CAPILLARY TUBE, BLOOD COLLECTION (K885138)Coeur Laboratories, Inc.1989-02-07
SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE (K884623)Safe-Tec Clinical Products, Inc.1988-12-01
NATELSON TUBES, HEPARIN AND PLAIN (K881187)Helps Products, Inc.1988-05-06
CARAWAY TUBES, HEPARIN AND PLAIN (K881262)Helps Products, Inc.1988-05-06
MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR (K875061)Sherwood Medical Co.1988-01-12
VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE (K873647)Ventrex Laboratories, Inc.1987-10-20
CORNING BLOOD COLLECTION CAPILLARY TUBES (K850806)Corning Medical & Scientific1985-03-25
CAPILLARY BLOOD COLLECTION TUBE (K843608)Medical Technomics, Ltd.1984-11-30
MICRO HEMATOCRIT CAPILLARY TUBES (K843892)Abco Dealers, Inc.1984-11-13
MINICAPS (K843361)Medical Technomics, Ltd.1984-09-21
RINGCAPS (K843362)Medical Technomics, Ltd.1984-09-21
MONOJET SAMPLETTE ADAPTERS (K832578)Sherwood Medical Co.1983-08-31
S/P CAPILLARY TUBES, HEPARINIZED (2A) (K812969)American Dade1981-11-06
S/P SURE-CAP (K812921)American Dade1981-11-06
S/P SURE-CAP N (K812923)American Dade1981-11-06
S/P CAPILLARY TUBES, HEPARINIZED (3A) (K812970)American Dade1981-11-06
S/P SURE-CAP C (K812922)American Dade1981-11-06
LANCER CAPILLARY BLOOD SERUM SEPARATOR (K770981)Sherwood Medical Industries1977-07-11

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