Product Code: BZK FDA class 2 21 CFR 868.1850

Spirometer, Monitoring (W/Wo Alarm)

Anesthesiology

The Spirometer, Monitoring (W/Wo Alarm) is a device used during mechanical ventilation to continuously measure exhaled tidal and minute volumes, often equipped with alarms to alert clinicians to changes in the patient's ventilatory status. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BZK, regulated under 21 CFR 868.1850 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: BZK
Device Class: FDA class 2
Regulation Number: 868.1850
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 61 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K192584	BEACON Caresystem Model 00002144	Dec 18, 2019	Substantially Equivalent	Mermaid Care A/S
K192595	ExSpiron 2Xi	Dec 17, 2019	Substantially Equivalent	Respiratory Motion
K180788	Gas Module 3	Oct 24, 2018	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K173181	ExSpiron 1Xi	Mar 16, 2018	Substantially Equivalent	Respiratory Motion, Inc.
K162131	ExSpiron 1Xi	May 09, 2017	Substantially Equivalent	Respiratory Motion, Inc.
K130170	EXSPIRON 1XI	May 29, 2013	Substantially Equivalent	Respiratory Motion, Inc.
K120087	EXSPIRON	Sep 26, 2012	Substantially Equivalent	Respiratory Motion, Inc.
K103578	PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST	Jun 02, 2011	Substantially Equivalent	Respironics Novametrix, LLC
K091853	WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014	Sep 21, 2009	Substantially Equivalent	Nspire Health, Inc.
K092217	MERCURY VCO2	Aug 21, 2009	Substantially Equivalent	Respironics Novametrix, Inc.
K091459	PHILIPS NM3 MONITOR, MODEL 7900	Jul 28, 2009	Substantially Equivalent	Respironics Novametrix, LLC
K080652	MERCURY VCO2 MODULE WITH CAPNOSTAT 5	Jun 20, 2008	Substantially Equivalent	Respironics Novametrix, LLC
K062754	GAS MODULE SE, MODEL 0998-00-0481-02	Nov 02, 2006	Substantially Equivalent	Datascope Corp.
K051279	CALDYNE, INC. EXHALOMETER EX100, MODEL EX100	Sep 07, 2005	Substantially Equivalent	Caldyne, Inc.
K983274	STARTRACK INFANT GRAPHICS MONITOR	Dec 09, 1998	Substantially Equivalent	Nellcor Puritan Bennett, Inc.
K972086	ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311	Aug 12, 1997	Substantially Equivalent	Alexander Mfg. Co.
K932098	CAPNOMAC ULTIMA ANESTHESIA MONITOR	Nov 29, 1993	Substantially Equivalent	Datex Division Instrumentarium Corp.
K931542	NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR	Oct 25, 1993	Substantially Equivalent	Newport Medical Instruments, Inc.
K921717	BICORE SMARTVALVE OCCLUSION VALVE	Nov 06, 1992	Substantially Equivalent	Bicore Monitoring Systems
K903674	MODEL 295 ELECTRONIC RESPIROMETER	Jan 04, 1991	Substantially Equivalent	National Medical Sales, Inc.
K903959	NEONATAL METASCOPE	Nov 23, 1990	Substantially Equivalent	Cybermedic, Inc.
K901885	PARTNER VOLUME MONITOR	Sep 27, 1990	Substantially Equivalent	Bird Products Corp.
K890932	CAV 3.0C SOFTWARE PROGRAM	Jun 12, 1989	Substantially Equivalent	Siemens Life Support Systems
K884910	MODEL 1010, CY-MET	Jun 12, 1989	Substantially Equivalent	Cybermedic, Inc.
K884959	RESPITRAK	Jun 08, 1989	Substantially Equivalent	Non-Invasive Monitoring Systems, Inc.
K884942	MONAGHAN RVM, MODEL 761	Jun 07, 1989	Substantially Equivalent	Monaghan Medical Corp.
K890724	MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR	Mar 30, 1989	Substantially Equivalent	Bear Medical Systems, Inc.
K872660	BEAR NVM-1	Feb 12, 1988	Substantially Equivalent	Bear Medical Systems, Inc.
K864886	RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL	Mar 06, 1987	Substantially Equivalent	Nims/Respitrace Corp.
K863866	RESPIRADYNE II(TM)	Jan 28, 1987	Substantially Equivalent	Chesebrough-Pond'S U.S.A. Co.
K863538	RESPICENTRAL(TM)	Sep 24, 1986	Substantially Equivalent	Dickstein, Shapiro & Morin
K862688	OHMEDA 5420 VOLUME MONITOR	Sep 12, 1986	Substantially Equivalent	Ohmeda Medical
K862687	OHMEDA 5410 VOLUME MONITOR	Sep 12, 1986	Substantially Equivalent	Ohmeda Medical
K854956	RESPIGRAPH	Mar 20, 1986	Substantially Equivalent	Respitrace Corp.
K853346	BEAR NICU-1	Sep 11, 1985	Substantially Equivalent	Bear Medical Systems, Inc.
K852692	RESPITRACE 300SC	Jul 15, 1985	Substantially Equivalent	Respitrace Corp.
K843800	OHMEDA RM121 RESPIROMETER	Oct 04, 1984	Substantially Equivalent	Ohmeda Medical
K843799	OHMEDA RM311 RESPIROMETER	Oct 04, 1984	Substantially Equivalent	Ohmeda Medical
K840975	RICO RESPIRATION MONITOR	Mar 30, 1984	Substantially Equivalent	J.M. Laboratories, Inc.
K840453	MEDISHIELD PVM RESPIROMETER	Mar 02, 1984	Substantially Equivalent	Ohio Medical Products
K823780	RESPITRACE 300SC	Jan 20, 1984	Substantially Equivalent	Respitrace Corp.
K823783	RESPICOMB	Jan 11, 1984	Substantially Equivalent	Respitrace Corp.
K832565	OHIO 5400 VOLUME MONITOR	Sep 01, 1983	Substantially Equivalent	Airco/Ohio Medical Products
K822689	PORTABLE MONITORING & SCREENING SPIROM.	Jul 12, 1983	Substantially Equivalent	Boehringer Laboratories
K831237	SPIROMED RESPIROMETER	May 09, 1983	Substantially Equivalent	Draeger Medical, Inc.
K830995	POCKET SPIROMETER	Apr 28, 1983	Substantially Equivalent	P.K. Morgan Instruments, Inc.
K823782	RESPITRACE SYSTEM	Mar 07, 1983	Substantially Equivalent	Respitrace Corp.
K823922	COMPUTERIZED SPIROMETRY SYSTEM	Feb 24, 1983	Substantially Equivalent	Ohio Medical Products
K823555	MAGTARAK RESPIRATORY MONITOR & FLOW SENS	Jan 05, 1983	Substantially Equivalent	Penlon, Inc.
K822912	BEAR VM-90 VENTILATION MONITOR	Nov 16, 1982	Substantially Equivalent	Bear Medical Systems, Inc.
K812959	SPIROX A	Jan 22, 1982	Substantially Equivalent	Cairco , Ltd.
K812956	SPIROX H	Jan 22, 1982	Substantially Equivalent	Cairco , Ltd.
K812046	TIDAL VOLUME MONITOR 150	Aug 07, 1981	Substantially Equivalent	Medix Medical Electronics (U.S.A.), Inc.
K800086	RMS 111F RESPIRATORY MONITORING SYSTEM	May 08, 1980	Substantially Equivalent	The Perkin-Elmer Corp.
K792573	ALARM USED W/MONITORING SPIROMETER	Dec 31, 1979	Substantially Equivalent	Empire Plastics Manufacturer
K792572	EMPIRE SPIROMETER	Dec 19, 1979	Substantially Equivalent	Empire Plastics Manufacturer
K782145	SPIROMETER, MINI POSITIVE	Jan 31, 1979	Substantially Equivalent	Boehringer Laboratories
K780064	SPIROMETER, MONITORING W/ALARM	Jan 31, 1978	Substantially Equivalent	Ohio Medical Products
K772016	RESPITRACE	Jan 26, 1978	Substantially Equivalent	Respitrace Corp.
K770907	SPIROMETEO EXHAUST	Jul 05, 1977	Substantially Equivalent	Timeter Instrument Corp.
K760971	POSITIVE DISPLACEMENT SPIROMETER	Dec 09, 1976	Substantially Equivalent	Boehringer Laboratories