Atlas FDA

DTW

17 FDA 510(k) clearances · Product code

77 daysmedian time to decision
190 days90th percentile
17clearances measured

FDA profile

Official device name
Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4340
Medical specialty
Cardiovascular
Adverse events (MAUDE)
2012: 20 · 2013: 6 · 2015: 11 · 2016: 22 · 2017: 47 · 2019: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Level Sensor, Level Sensor Tape (K150530)Medtronic, Inc.2015-05-08
STOCKERTIR PURGE CONTROL (APC) SYSTEM (K041558)Stockert Instrumente GmbH2004-07-02
LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070 (K992857)Rocky Mountain Research, Inc.1999-11-10
STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER (K955152)Stoeckert Instrumente1996-02-22
CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR (K910599)Jtl Medical Corp.1993-05-20
STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR (K924354)Sorin Biomedica, Fiat, USA, Inc.1993-02-18
CAPIOX LEVEL ALARM (K915337)Terumo Medical Corp.1992-02-21
COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) (K900910)Cobe Laboratories, Inc.1990-05-22
SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL (K900815)3M Company1990-05-09
MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE (K873206)Respiratory Support Products, Inc.1987-09-30
GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 (K860076)Gambro, Inc.1986-05-30
SENSOR TAPE CAT. NO. ST-45 (K852407)American Omni Medical, Inc.1985-10-21
STOCKERT-SHILEY UNIVERSAL LEVEL SENSOR (K843802)Shiley, Inc.1984-12-27
UNIVERSAL LEVEL SENSOR (K831879)3M Health Care, Sarns1983-07-26
BEL BLOOD LEVEL DETECTOR (K823712)R. Scott Bell1983-02-07
GAMBRO BLOOD LEVEL DETECTOR LCS 10 (K822821)Gambro, Inc.1982-10-18
MONITOR KITS, BLOOD LEVEL (K781145)3M Health Care, Sarns1978-07-27

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