Atlas FDA

BZK

61 FDA 510(k) clearances · Product code

87 daysmedian time to decision
212 days90th percentile
61clearances measured

FDA profile

Official device name
Spirometer, Monitoring (W/Wo Alarm)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1850
Medical specialty
Anesthesiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2002: 2 · 2003: 1 · 2004: 1 · 2013: 73 · 2014: 31 · 2015: 12
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
BEACON Caresystem Model 00002144 (K192584)Mermaid Care A/S2019-12-18
ExSpiron 2Xi (K192595)Respiratory Motion2019-12-17
Gas Module 3 (K180788)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2018-10-24
ExSpiron 1Xi (K173181)Respiratory Motion, Inc.2018-03-16
ExSpiron 1Xi (K162131)Respiratory Motion, Inc.2017-05-09
EXSPIRON 1XI (K130170)Respiratory Motion, Inc.2013-05-29
EXSPIRON (K120087)Respiratory Motion, Inc.2012-09-26
PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST (K103578)Respironics Novametrix, LLC2011-06-02
WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014 (K091853)Nspire Health, Inc.2009-09-21
MERCURY VCO2 (K092217)Respironics Novametrix, Inc.2009-08-21
PHILIPS NM3 MONITOR, MODEL 7900 (K091459)Respironics Novametrix, LLC2009-07-28
MERCURY VCO2 MODULE WITH CAPNOSTAT 5 (K080652)Respironics Novametrix, LLC2008-06-20
GAS MODULE SE, MODEL 0998-00-0481-02 (K062754)Datascope Corp.2006-11-02
CALDYNE, INC. EXHALOMETER EX100, MODEL EX100 (K051279)Caldyne, Inc.2005-09-07
STARTRACK INFANT GRAPHICS MONITOR (K983274)Nellcor Puritan Bennett, Inc.1998-12-09
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311 (K972086)Alexander Mfg. Co.1997-08-12
CAPNOMAC ULTIMA ANESTHESIA MONITOR (K932098)Datex Division Instrumentarium Corp.1993-11-29
NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR (K931542)Newport Medical Instruments, Inc.1993-10-25
BICORE SMARTVALVE OCCLUSION VALVE (K921717)Bicore Monitoring Systems1992-11-06
MODEL 295 ELECTRONIC RESPIROMETER (K903674)National Medical Sales, Inc.1991-01-04
NEONATAL METASCOPE (K903959)Cybermedic, Inc.1990-11-23
PARTNER VOLUME MONITOR (K901885)Bird Products Corp.1990-09-27
CAV 3.0C SOFTWARE PROGRAM (K890932)Siemens Life Support Systems1989-06-12
MODEL 1010, CY-MET (K884910)Cybermedic, Inc.1989-06-12
RESPITRAK (K884959)Non-Invasive Monitoring Systems, Inc.1989-06-08
MONAGHAN RVM, MODEL 761 (K884942)Monaghan Medical Corp.1989-06-07
MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR (K890724)Bear Medical Systems, Inc.1989-03-30
BEAR NVM-1 (K872660)Bear Medical Systems, Inc.1988-02-12
RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL (K864886)Nims/Respitrace Corp.1987-03-06
RESPIRADYNE II(TM) (K863866)Chesebrough-Pond'S U.S.A. Co.1987-01-28
RESPICENTRAL(TM) (K863538)Dickstein, Shapiro & Morin1986-09-24
OHMEDA 5410 VOLUME MONITOR (K862687)Ohmeda Medical1986-09-12
OHMEDA 5420 VOLUME MONITOR (K862688)Ohmeda Medical1986-09-12
RESPIGRAPH (K854956)Respitrace Corp.1986-03-20
BEAR NICU-1 (K853346)Bear Medical Systems, Inc.1985-09-11
RESPITRACE 300SC (K852692)Respitrace Corp.1985-07-15
OHMEDA RM311 RESPIROMETER (K843799)Ohmeda Medical1984-10-04
OHMEDA RM121 RESPIROMETER (K843800)Ohmeda Medical1984-10-04
RICO RESPIRATION MONITOR (K840975)J.M. Laboratories, Inc.1984-03-30
MEDISHIELD PVM RESPIROMETER (K840453)Ohio Medical Products1984-03-02
RESPITRACE 300SC (K823780)Respitrace Corp.1984-01-20
RESPICOMB (K823783)Respitrace Corp.1984-01-11
OHIO 5400 VOLUME MONITOR (K832565)Airco/Ohio Medical Products1983-09-01
PORTABLE MONITORING & SCREENING SPIROM. (K822689)Boehringer Laboratories1983-07-12
SPIROMED RESPIROMETER (K831237)Draeger Medical, Inc.1983-05-09
POCKET SPIROMETER (K830995)P.K. Morgan Instruments, Inc.1983-04-28
RESPITRACE SYSTEM (K823782)Respitrace Corp.1983-03-07
COMPUTERIZED SPIROMETRY SYSTEM (K823922)Ohio Medical Products1983-02-24
MAGTARAK RESPIRATORY MONITOR & FLOW SENS (K823555)Penlon, Inc.1983-01-05
BEAR VM-90 VENTILATION MONITOR (K822912)Bear Medical Systems, Inc.1982-11-16
SPIROX A (K812959)Cairco , Ltd.1982-01-22
SPIROX H (K812956)Cairco , Ltd.1982-01-22
TIDAL VOLUME MONITOR 150 (K812046)Medix Medical Electronics (U.S.A.), Inc.1981-08-07
RMS 111F RESPIRATORY MONITORING SYSTEM (K800086)The Perkin-Elmer Corp.1980-05-08
ALARM USED W/MONITORING SPIROMETER (K792573)Empire Plastics Manufacturer1979-12-31
EMPIRE SPIROMETER (K792572)Empire Plastics Manufacturer1979-12-19
SPIROMETER, MINI POSITIVE (K782145)Boehringer Laboratories1979-01-31
SPIROMETER, MONITORING W/ALARM (K780064)Ohio Medical Products1978-01-31
RESPITRACE (K772016)Respitrace Corp.1978-01-26
SPIROMETEO EXHAUST (K770907)Timeter Instrument Corp.1977-07-05
POSITIVE DISPLACEMENT SPIROMETER (K760971)Boehringer Laboratories1976-12-09

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