Atlas FDA

CCE

23 FDA 510(k) clearances · Product code

91 daysmedian time to decision
318 days90th percentile
23clearances measured

FDA profile

Official device name
Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1200
Medical specialty
Anesthesiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2002: 38 · 2003: 19 · 2004: 24 · 2005: 9 · 2006: 15 · 2007: 2
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
VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM (K935778)Via Medical Corp.1996-12-05
SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA (K912145)S & W Medico Teknik1992-05-05
TOPS NEEDLE TIP PROBE & PVC TIP PROBE (K910453)Baxter Healthcare Corp1991-08-13
PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM (K905397)Puritan Bennett Corp.1991-05-14
OPTEX BLOOD GAS MONITORING SYSTEM (K896311)Optex Biomedical1990-01-03
TISSUE OXYGEN MONITOR SYSTEM, MODEL II (K890624)Baxter Healthcare Corp1989-12-22
NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY (K895149)Shiley, Inc.1989-11-28
CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING (K895150)Shiley, Inc.1989-11-28
BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM (K884063)C.R. Bard, Inc.1988-12-16
UMBILICAL ARTERY OXYGEN SENSOR (K875225)Ohmeda Medical1988-03-04
UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100 (K872896)American Bentley1988-02-12
BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR. SYSTEM (K872125)C.R. Bard, Inc.1987-12-11
CONTINUCATH (K860808)Orange Medical Instruments, Inc.1986-03-13
OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100 (K860106)American Bentley1986-02-26
OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100 (K853786)American Bentley1985-10-16
INTRAVASCULAR BLOOD GAS SYSTEM (K843912)Cardiovascular Devices, Inc.1985-01-10
ARTERIAL BLOOD GAS INTERPRETATION PROG (K840102)M. D. Software, Inc.1984-02-04
NEOCATH 1000 W/HEPCOTE (K832793)Orange Medical Instruments, Inc.1983-09-26
VENOUS OXYGEN PROBE (K811071)G.D. Searle and Co.1981-05-05
MONITOR, PO2, INTRAVASCULAR (K781271)Roche Medical Electronics, Inc.1978-10-12
SEARLE NEONATAL OXYGEN PROBE (K780850)Will Ross Co.1978-08-23
CATHETER, PO2, INTRAVASUCLAR, CITADEL (K771116)Sherwood Medical Industries1977-09-15
MONITOR, CITADEL INTRAVASCULAR PO2 (K760350)Sherwood Medical Industries1976-10-29

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