Panels › Anesthesiology › Product code BZK · Class 2
Spirometer, Monitoring (W/Wo Alarm)
Regulation 868.1850
1510(k)s in 12 months (62 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in BZK
| Company | 510(k)s | Recalls |
|---|---|---|
| Respironics Novametrix, Inc. | 4 | 2 |
| Respitrace Corp. | 6 | 0 |
| Respiratory Motion | 5 | 0 |
| Bear Medical Systems, Inc. | 4 | 0 |
| Ohmeda Medical | 4 | 0 |
| Boehringer Laboratories | 3 | 0 |
| Ohio Medical Products | 3 | 0 |
| Cairco , Ltd. | 2 | 0 |
| Cybermedic, Inc. | 2 | 0 |
| Empire Plastics Manufacturer | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 16, 2026 | K260226 | ElintMAX Respiratory Monitor (ElintMAX Monitor A1) Amptron Medical, Inc. | BZK |
| Dec 18, 2019 | K192584 | BEACON Caresystem Model 00002144 Mermaid Care A/S, DK | BZK |
| Dec 17, 2019 | K192595 | ExSpiron 2Xi Respiratory Motion | BZK |
| Oct 24, 2018 | K180788 | Gas Module 3 Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | BZK |
| Mar 16, 2018 | K173181 | ExSpiron 1Xi Respiratory Motion, Inc. | BZK |
| May 9, 2017 | K162131 | ExSpiron 1Xi Respiratory Motion, Inc. | BZK |
| May 29, 2013 | K130170 | EXSPIRON 1XI Respiratory Motion, Inc. | BZK |
| Sep 26, 2012 | K120087 | EXSPIRON Respiratory Motion, Inc. | BZK |
| Jun 2, 2011 | K103578 | PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST Respironics Novametrix, LLC | BZK |
| Sep 21, 2009 | K091853 | WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014 Nspire Health, Inc. | BZK |
| Aug 21, 2009 | K092217 | MERCURY VCO2 Respironics Novametrix, Inc. | BZK |
| Jul 28, 2009 | K091459 | PHILIPS NM3 MONITOR, MODEL 7900 Respironics Novametrix, LLC | BZK |
| Jun 20, 2008 | K080652 | MERCURY VCO2 MODULE WITH CAPNOSTAT 5 Respironics Novametrix, LLC | BZK |
| Nov 2, 2006 | K062754 | GAS MODULE SE, MODEL 0998-00-0481-02 Datascope Corp. | BZK |
| Sep 7, 2005 | K051279 | CALDYNE, INC. EXHALOMETER EX100, MODEL EX100 Caldyne, Inc. | BZK |
| Dec 9, 1998 | K983274 | STARTRACK INFANT GRAPHICS MONITOR Nellcor Puritan Bennett, Inc. | BZK |
| Aug 12, 1997 | K972086 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311 Alexander Mfg. Co. | BZK |
| Nov 29, 1993 | K932098 | CAPNOMAC ULTIMA ANESTHESIA MONITOR Datex Division Instrumentarium Corp., FI | BZK |
| Oct 25, 1993 | K931542 | NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR Newport Medical Instruments, Inc. | BZK |
| Nov 6, 1992 | K921717 | BICORE SMARTVALVE OCCLUSION VALVE Bicore Monitoring Systems | BZK |
| Jan 4, 1991 | K903674 | MODEL 295 ELECTRONIC RESPIROMETER National Medical Sales, Inc. | BZK |
| Nov 23, 1990 | K903959 | NEONATAL METASCOPE Cybermedic, Inc. | BZK |
| Sep 27, 1990 | K901885 | PARTNER VOLUME MONITOR Bird Products Corp. | BZK |
| Jun 12, 1989 | K890932 | CAV 3.0C SOFTWARE PROGRAM Siemens Life Support Systems | BZK |
| Jun 12, 1989 | K884910 | MODEL 1010, CY-MET Cybermedic, Inc. | BZK |
| Jun 8, 1989 | K884959 | RESPITRAK Non-Invasive Monitoring Systems, Inc. | BZK |
| Jun 7, 1989 | K884942 | MONAGHAN RVM, MODEL 761 Monaghan Medical Corp. | BZK |
| Mar 30, 1989 | K890724 | MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR Bear Medical Systems, Inc. | BZK |
| Feb 12, 1988 | K872660 | BEAR NVM-1 Bear Medical Systems, Inc. | BZK |
| Mar 6, 1987 | K864886 | RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL Nims/Respitrace Corp. | BZK |
| Jan 28, 1987 | K863866 | RESPIRADYNE II(TM) Chesebrough-Pond'S U.S.A. Co. | BZK |
| Sep 24, 1986 | K863538 | RESPICENTRAL(TM) Dickstein, Shapiro & Morin | BZK |
| Sep 12, 1986 | K862688 | OHMEDA 5420 VOLUME MONITOR Ohmeda Medical | BZK |
| Sep 12, 1986 | K862687 | OHMEDA 5410 VOLUME MONITOR Ohmeda Medical | BZK |
| Mar 20, 1986 | K854956 | RESPIGRAPH Respitrace Corp. | BZK |
| Sep 11, 1985 | K853346 | BEAR NICU-1 Bear Medical Systems, Inc. | BZK |
| Jul 15, 1985 | K852692 | RESPITRACE 300SC Respitrace Corp. | BZK |
| Oct 4, 1984 | K843800 | OHMEDA RM121 RESPIROMETER Ohmeda Medical | BZK |
| Oct 4, 1984 | K843799 | OHMEDA RM311 RESPIROMETER Ohmeda Medical | BZK |
| Mar 30, 1984 | K840975 | RICO RESPIRATION MONITOR J.M. Laboratories, Inc. | BZK |
| Mar 2, 1984 | K840453 | MEDISHIELD PVM RESPIROMETER Ohio Medical Products | BZK |
| Jan 20, 1984 | K823780 | RESPITRACE 300SC Respitrace Corp. | BZK |
| Jan 11, 1984 | K823783 | RESPICOMB Respitrace Corp. | BZK |
| Sep 1, 1983 | K832565 | OHIO 5400 VOLUME MONITOR Airco/Ohio Medical Products | BZK |
| Jul 12, 1983 | K822689 | PORTABLE MONITORING & SCREENING SPIROM. Boehringer Laboratories | BZK |
| May 9, 1983 | K831237 | SPIROMED RESPIROMETER Draeger Medical, Inc. | BZK |
| Apr 28, 1983 | K830995 | POCKET SPIROMETER P.K. Morgan Instruments, Inc. | BZK |
| Mar 7, 1983 | K823782 | RESPITRACE SYSTEM Respitrace Corp. | BZK |
| Feb 24, 1983 | K823922 | COMPUTERIZED SPIROMETRY SYSTEM Ohio Medical Products | BZK |
| Jan 5, 1983 | K823555 | MAGTARAK RESPIRATORY MONITOR & FLOW SENS Penlon, Inc. | BZK |
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