BZK · Class II · 21 CFR 868.1850

FDA Product Code BZK: Spirometer, Monitoring (w/wo Alarm)

Leading manufacturers include Respitrace Corp., Bear Medical Systems, Inc. and Respiratory Motion, Inc..

62
Total
62
Cleared
109d
Avg days
1976
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 233d recently vs 107d historically

FDA 510(k) Cleared Spirometer, Monitoring (w/wo Alarm) Devices (Product Code BZK)

62 devices
1–24 of 62
Cleared Sep 16, 2026
ElintMAX Respiratory Monitor (ElintMAX Monitor A1)
K260226
Amptron Medical, Inc.
Anesthesiology · 233d
Cleared Dec 18, 2019
BEACON Caresystem Model 00002144
K192584
Mermaid Care A/S
Anesthesiology · 90d
Cleared Dec 17, 2019
ExSpiron 2Xi
K192595
Respiratory Motion
Anesthesiology · 88d
Cleared Oct 24, 2018
Gas Module 3
K180788
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Anesthesiology · 212d
Cleared Mar 16, 2018
ExSpiron 1Xi
K173181
Respiratory Motion, Inc.
Anesthesiology · 168d
Cleared May 09, 2017
ExSpiron 1Xi
K162131
Respiratory Motion, Inc.
Anesthesiology · 281d
Cleared May 29, 2013
EXSPIRON 1XI
K130170
Respiratory Motion, Inc.
Anesthesiology · 125d
Cleared Sep 26, 2012
EXSPIRON
K120087
Respiratory Motion, Inc.
Anesthesiology · 259d
Cleared Jun 02, 2011
PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST
K103578
Respironics Novametrix, LLC
Anesthesiology · 178d
Cleared Sep 21, 2009
WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014
K091853
Nspire Health, Inc.
Anesthesiology · 90d
Cleared Aug 21, 2009
MERCURY VCO2
K092217
Respironics Novametrix, Inc.
Anesthesiology · 30d
Cleared Jul 28, 2009
PHILIPS NM3 MONITOR, MODEL 7900
K091459
Respironics Novametrix, LLC
Anesthesiology · 71d
Cleared Jun 20, 2008
MERCURY VCO2 MODULE WITH CAPNOSTAT 5
K080652
Respironics Novametrix, LLC
Anesthesiology · 105d
Cleared Nov 02, 2006
GAS MODULE SE, MODEL 0998-00-0481-02
K062754
Datascope Corp.
Anesthesiology · 49d
Cleared Sep 07, 2005
CALDYNE, INC. EXHALOMETER EX100, MODEL EX100
K051279
Caldyne, Inc.
General Hospital · 113d
Cleared Dec 09, 1998
STARTRACK INFANT GRAPHICS MONITOR
K983274
Nellcor Puritan Bennett, Inc.
Anesthesiology · 83d
Cleared Aug 12, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311
K972086
Alexander Mfg. Co.
Anesthesiology · 69d
Cleared Nov 29, 1993
CAPNOMAC ULTIMA ANESTHESIA MONITOR
K932098
Datex Division Instrumentarium Corp.
Anesthesiology · 210d
Cleared Oct 25, 1993
NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR
K931542
Newport Medical Instruments, Inc.
Anesthesiology · 210d
Cleared Nov 06, 1992
BICORE SMARTVALVE OCCLUSION VALVE
K921717
Bicore Monitoring Systems
Anesthesiology · 211d
Cleared Jan 04, 1991
MODEL 295 ELECTRONIC RESPIROMETER
K903674
National Medical Sales, Inc.
Anesthesiology · 144d
Cleared Nov 23, 1990
NEONATAL METASCOPE
K903959
Cybermedic, Inc.
Anesthesiology · 87d
Cleared Sep 27, 1990
PARTNER VOLUME MONITOR
K901885
Bird Products Corp.
Anesthesiology · 154d
Cleared Jun 12, 1989
MODEL 1010, CY-MET
K884910
Cybermedic, Inc.
Anesthesiology · 199d

About Product Code BZK - Regulatory Context

510(k) Submission Activity

62 total 510(k) submissions under product code BZK since 1976, with 62 receiving FDA clearance (average review time: 109 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - BZK Product Code

Recent submissions under BZK have taken an average of 233 days to reach a decision - up from 107 days historically. Manufacturers should account for longer review timelines in current project planning.

BZK devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →