BZC · Class II · 21 CFR 868.1880

FDA Product Code BZC: Calculator, Pulmonary Function Data

Leading manufacturers include Erich Jaeger, Inc., Novametrix Medical Systems, Inc. and P.K. Morgan , Ltd..

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 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 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
Cleared Apr 01, 1997
BENCHMARK TRANSFER TEST
K954730
P.K. Morgan , Ltd.
Anesthesiology · 533d
Cleared Mar 06, 1997
THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS
K964939
Creative Biomedics, Inc.
Anesthesiology · 86d
Cleared Jan 22, 1997
CO 2 SMO PLUS
K963380
Novametrix Medical Systems, Inc.
Anesthesiology · 148d
Cleared Jan 09, 1997
AUTOLINK BODY PLETHYSMOGRAPH
K960121
P.K. Morgan , Ltd.
Anesthesiology · 364d
Cleared Dec 09, 1996
TRANSFLOW TEST
K953990
P.K. Morgan , Ltd.
Anesthesiology · 473d
Cleared May 29, 1996
VENTRAK RMMS 1550
K960831
Novametrix Medical Systems, Inc.
Anesthesiology · 90d
Cleared Apr 23, 1996
ACKRAD ESOPHAGEAL BALLOON CATHETER SET
K952542
Ackrad Laboratories
Anesthesiology · 336d

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.