Atlas FDA

KLK

47 FDA 510(k) clearances · Product code

60 daysmedian time to decision
248 days90th percentile
47clearances measured

FDA profile

Official device name
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Device class
Class II (moderate risk)
Regulation
21 CFR 868.2500
Medical specialty
Anesthesiology
Adverse events (MAUDE)
1994: 1 · 1997: 2 · 1998: 2 · 1999: 1 · 2005: 2 · 2007: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
MICROGAS 7650 TRANSCUTANEOUS MONITOR (K003943)Linde Medical Sensors AG2001-05-04
MICROGAS 7650 TRANSCUTANEOUS MONITOR (K991644)Linde Medical Sensors AG1999-05-21
SIEMENS SC9000/SC9015 TCP02/C02 MODULE (K980287)Siemens Medical Solutions USA, Inc.1998-08-12
SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE (K924709)Air-Shields, Inc.1996-01-17
OXYCARE(TM) OXYGEN CONTROLLER/MONITOR (K924679)Air-Shields Vickers, Inc.1995-02-21
HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE (K925910)Hewlett-Packard Co.1993-07-29
HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX (K893133)Mennen Medical, Inc.1989-07-14
MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR (K870805)Novametrix Medical Systems, Inc.1987-05-27
515A NEO-TRAK NEONATAL MONITOR (K861861)Ge Medical Systems Information Technologies1986-07-10
HORIZON 2000 TRANSCUTANEOUS GAS MONITORING (K860124)Mennen Medical, Inc.1986-05-09
KONTRON CUTANEOUS PO2 MONITOR 820 (K860951)Kontron Instruments, Inc.1986-04-09
PO-510 TCPO2 MONITOR (K852959)Sumitomo Electric Industries, Inc.1985-11-29
STAT GAS MODULE (K851451)Vulcan Laboratories, Inc.1985-08-02
NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2 (K844253)Novametrix Medical Systems, Inc.1985-01-10
NOVAMETRIX 860 PROTA. TRANSCUTANEOUS OXYGEN (K844079)Novametrix Medical Systems, Inc.1984-11-30
SERVOMED OXYMONITO SMK 363 (K842497)Litton Datamedix1984-10-04
NOVAMETRIX 850 TRANSCUTANEOUS OXYGEN (K842374)Novametrix Medical Systems, Inc.1984-09-17
TRANSCUTANEOUS 800-OXYGEN MONITORS/801 (K840993)Novametrix Medical Systems, Inc.1984-04-24
MICRO SPAN TRANSCUTANEOUS OXYGEN MONIT (K840918)Biochem International, Inc.1984-04-17
DAYPAK SYS VII CATHETER CARE KIT (K840919)Creative Care Systems, Inc.1984-04-17
PATIENT MONITOR #404 (K831319)Analogic Corp.1984-03-22
IL 301 PORTABLE TRANSCUT. OXYGEN MONI (K834057)Instrumentation Laboratory CO1984-02-04
OXY MONITOR 5-RANGE DUAL-THERMISTOR (K832652)Litton Medical Electronics1983-12-22
TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS (K830197)Diamond Shamrock Corp.1983-11-29
TRANSCUTANEOUS OXYGEN MONITOR OPTION (K831744)Ge Medical Systems Information Technologies1983-07-19
AS 30/TCP MODULE (K831460)Narco Scientific1983-07-12
IL 301 TRANSCUTANEOUS OXYGEN MONITOR (K822328)Instrumentation Laboratory CO1982-09-07
CRITIKON OXYGEN MONITOR, MODEL 8030 (K821936)Critikon Company, LLC1982-08-16
NOVAMETRIX MODEL 807 TRANSCUT. MONITOR (K813350)Novametrix Medical Systems, Inc.1982-02-12
CRITIKON TRANSCUTANEOUS GAS MONITORS (K813347)Critikon Company, LLC1982-01-26
NOVAMETRIX MODEL 816A TRANSCUT. OXYGEN (K813352)Novametrix Medical Systems, Inc.1982-01-07
NOVAMETRIX NAVAGRAPH MODEL 312 RECORDER (K813351)Novametrix Medical Systems, Inc.1981-12-31
MODEL 78850 OXYGEN MONITOR (K812167)Hewlett-Packard Co.1981-08-31
PO-200 BLOOD OXYGEN MONITOR (K811836)Sumitomo Electric Industries, Inc.1981-07-27
CORDIS TCPO2 TRANCUTANEOUS OXYGEN PRESS (K810999)Cordis Corp.1981-06-24
LIFESPAN 100 (K811470)Biochem International, Inc.1981-06-12
TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300 (K802978)Brattle Instrument Corp.1981-02-02
TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY. (K802846)The London Co.1980-12-17
NOVAMETRIX TCOMETTE #809 TRANS. MONITOR (K800988)Novametrix Medical Systems, Inc.1980-05-28
OXYMETER (K800631)Dragerwerk AG1980-04-02
ROCHE SENSOR ADAPTOR (K791559)Roche Medical Electronics, Inc.1979-11-21
TC02M PRECISION GAS CALIBRATOR (K792011)Novametrix Medical Systems, Inc.1979-11-16
TC02 M OXYGEN ELECTRODE CONTACT (K792009)Novametrix Medical Systems, Inc.1979-10-26
TC02M ELECTRODE ADHESIVE RINGS (K792010)Novametrix Medical Systems, Inc.1979-10-26
TCO2M MODEL 818 (K791152)Novametrix Medical Systems, Inc.1979-08-03
MONITOR, SENSOMATIII OXYGEN (K781910)Biochem International, Inc.1978-12-26
TRANSCUTANEOUS OXYGEN PERFUSION MONITOR (K780458)Narco Air-Shields1978-10-10

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