BZC · Class II · 21 CFR 868.1880

FDA Product Code BZC: Calculator, Pulmonary Function Data

Leading manufacturers include Erich Jaeger, Inc., Warren E. Collins, Inc. and Novametrix Medical Systems, Inc..

90
Total
90
Cleared
156d
Avg days
1977
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Calculator, Pulmonary Function Data Devices (Product Code BZC)

90 devices
1–24 of 90
Cleared Sep 17, 2024
STS
K240293
Techbopulm, Ltd.
Anesthesiology · 229d
Cleared Aug 23, 2019
Vyntus/SentrySuite Product Line
K183567
Vyaire Medical
Anesthesiology · 245d
Cleared Aug 16, 2019
Vyntus BODY
K190853
Vyaire Medical, Inc.
Anesthesiology · 136d
Cleared Nov 30, 2018
Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART
K181524
Vyaire Medical, Inc.
Anesthesiology · 172d
Cleared Jun 20, 2017
COSMED K5 Wearable Metabolic Technology
K162515
Cosmed Srl
Anesthesiology · 285d
Cleared Oct 21, 2016
MiniBox +
K161295
Pulmone Advanced Medical Devices, Ltd.
Anesthesiology · 165d
Cleared Aug 14, 2015
Vyntus / SentrySuite Product Line
K150810
Carefusion Germany 234 GmbH
Anesthesiology · 141d
Cleared Aug 22, 2014
VYNTUS/ SENTRYSUITE PRODUCT LINE
K133925
Carefusion Germany 234 GmbH
Anesthesiology · 242d
Cleared May 02, 2014
PULMONE MINIBOX PFT TM
K133051
Pulmone Advanced Medical Devices, Ltd.
Anesthesiology · 217d
Cleared Nov 01, 2011
LCI OPTION FOR INNOCOR
K102047
Innovision A/S
Anesthesiology · 468d
Cleared Oct 10, 2007
MASTERSCREEN & OXYCON CPX
K072323
Viasys Healthcare GmbH
Anesthesiology · 51d
Cleared Dec 22, 2005
ZAN LUNG-FUNCTION LAB
K052328
Zan Messgerate GmbH
Anesthesiology · 119d
Cleared Apr 07, 2004
MASTERSCREEN CPX AND OXYCON CPX
K040698
Viasys Healthcare GmbH
Anesthesiology · 21d
Cleared Nov 12, 2003
OXYCON MOBILE
K023120
Erich Jaeger GmbH
Anesthesiology · 419d
Cleared May 17, 2002
INFANT PLETHYSMOGRAPH, MODEL 004400
K011344
Collins Medical, Inc.
Anesthesiology · 380d
Cleared Feb 22, 2001
CORTEX METAMAX
K001631
Cortex Biophysik GmbH
Anesthesiology · 272d
Cleared Jan 11, 2001
COSMED QUARK
K001174
Cosmed Srl
Anesthesiology · 275d
Cleared Jul 12, 2000
AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO
K001502
Erich Jaeger GmbH
Anesthesiology · 58d
Cleared Feb 22, 2000
OXYCON PRO
K992214
Erich Jaeger B.V.
Anesthesiology · 236d
Cleared Oct 16, 1998
COSMO PLUS WITH NICO, MODEL 8200
K982499
Novametrix Medical Systems, Inc.
Anesthesiology · 88d
Cleared Oct 14, 1998
CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MONITOR METEOR 100, CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MO
K982487
Cardiopulmonary Technologies, Inc.
Anesthesiology · 89d
Cleared Nov 26, 1997
INTELLIFLOW RESPIRATORY ANALYZER
K970840
Simtec, Inc.
Anesthesiology · 264d
Cleared Sep 10, 1997
COSMED K4
K963373
Cosmed Srl
Anesthesiology · 379d
Cleared Apr 04, 1997
VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101
K964360
Novametrix Medical Systems, Inc.
Anesthesiology · 154d

About Product Code BZC - Regulatory Context

510(k) Submission Activity

90 total 510(k) submissions under product code BZC since 1977, with 90 receiving FDA clearance (average review time: 156 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.