BZC · Class II · 21 CFR 868.1880

FDA Product Code BZC: Calculator, Pulmonary Function Data

Leading manufacturers include Novametrix Medical Systems, Inc., Vyaire Medical, Inc. and Cavitron Corp..

90
Total
90
Cleared
156d
Avg days
1977
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 229d recently vs 155d historically

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 Oct 16, 1998
COSMO PLUS WITH NICO, MODEL 8200
K982499
Novametrix Medical Systems, Inc.
Anesthesiology · 88d
Cleared Apr 04, 1997
VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101
K964360
Novametrix Medical Systems, Inc.
Anesthesiology · 154d
Cleared Jan 22, 1997
CO 2 SMO PLUS
K963380
Novametrix Medical Systems, Inc.
Anesthesiology · 148d
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
Cleared Mar 31, 1989
Q-PLEX 1
K881235
Quinton, Inc.
Anesthesiology · 374d
Cleared Apr 10, 1981
PDS CARDIAC CALC. SOFTW. PROGR. #A3604AF
K810751
General Electric Co.
Anesthesiology · 21d
Cleared Feb 23, 1981
INSPIRON PULMONARY FUNCTION ANALYZER
K802920
C.R. Bard, Inc.
Anesthesiology · 97d
Cleared Dec 17, 1980
SPIROMETRIC COMPUTER #SC-10
K802928
Cavitron Corp.
Anesthesiology · 28d
Cleared Oct 03, 1980
ANESTHESIA GAS MACHINE
K802116
Puritan Bennett Corp.
Anesthesiology · 29d
Cleared Mar 14, 1978
ANALYZER, PULMONARY FUNCTION
K780322
Hospal Medical Corp.
Anesthesiology · 15d
Cleared Apr 05, 1977
PC-30 PULMONARY COMPUTER
K770532
Cavitron Corp.
Anesthesiology · 15d

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 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 - BZC Product Code

Recent submissions under BZC have taken an average of 229 days to reach a decision - up from 155 days historically. Manufacturers should account for longer review timelines in current project planning.

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