Product code BZG— Anesthesiology
ASTHMA MONITOR AM3
- Classification name
- Spirometer, Diagnostic
- Device class
- Class 2
- Regulation
- 21 CFR 868.1840
- Advisory panel
- Anesthesiology
- Total cleared
- 228
- First cleared
- Most recent
Market context for product code BZG
FDA has cleared devices under product code BZG between 1977 and 2026, filed by 127 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
Top applicants under product code BZG
Recent clearances under product code BZG
1–100 of 228- K251777 — MESI mTABLET SPIRO
- K241843 — TD-7301 Spirometer (TD-7301)
- K231416 — Air Next (NVD-02)
- K230501 — Spirobank Oxi
- K230178 — EasyOne Sky Spirometer
- K222525 — Alveoair Digital Spirometer
- K222443 — Air Smart Extra Spirometer
- K213754 — SpiroHome Personal, SpiroHome Clinic
- K213872 — ComPAS2
- K212938 — Vitalograph Model 6000 Alpha
- K201493 — Spirometer
- K202837 — GoSpiro
- K201562 — Spirotrac
- K201002 — Safey Pocket Spirometer
- K200550 — Vitalograph Model 2120 In2itive eDiary
- K183089 — Air Next
- K183479 — Asthma Monitor AM3
- K191013 — Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option
- K190568 — ComPAS2 (Computerized Pulmonary Analysis System)
- K180011 — Pulmonx Chartis Tablet Console
- K163249 — GoSpiro
- K161536 — EasyOne Air Spirometer
- K161676 — Q13 SPIROLYSER®
- K160116 — SpiroScout
- K160253 — Vitalograph Model 6300 micro
- K150515 — IQSense Flow Sensor Mouthpiece
- K142642 — Vitalograph Model 6600 Compact
- K142812 — Vitalograph Model 6800 Pneumotrac
- K120577 — MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX
- K150137 — SpiroThor
- K141793 — PULMONE MINIBOXPFT 2.0
- K141936 — MICROBLAB, MICROLOOP
- K142303 — NeumoFilt Ergo/Neumo Filt BiteOn
- K141546 — VITALOGRAPH MODEL 7000 SPIROTRAC
- K133428 — MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO
- K133722 — ASTHMA MONITOR AM3
- K130322 — SPM-300
- K130784 — SPIROTEL
- K123896 — CCS-200 SPIROMETER
- K122384 — MINISPIR
- K120880 — ORBIT
- K113096 — MICRO I
- K103530 — SPIRODOC
- K111764 — CHARTIS CONSOLE
- K103575 — SPIRO PD
- K111587 — ALERKAN SPIROMETRY FILTER
- K100928 — MICRO DIARY SPIROMETER
- K101873 — MASTERSCREEN IOS
- K100687 — VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120
- K092813 — ASTRASONIC SPIROMETER, MODEL 29-8000
- K093174 — SPIROPALM
- K092890 — ASTHMA MONITOR AM3
- K090646 — CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105
- K083199 — CHARTIS CONSOLE
- K090034 — EASY ON-PC SPIROMETER
- K090486 — ASTHMA MONITOR MODEL, AM1
- K082478 — WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62
- K083233 — THE PFT FILTER
- K083879 — INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500)
- K080921 — SPIRO-MASTER PC-10 SPIROMETRY SYSTEM
- K082766 — MODIFICATION TO MINISPIR, SPIROLAB III
- K073155 — VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)
- K072722 — MEDDORNA WIRELESS PRN SPIROMETER 100
- K072979 — SPIROBANK G
- K061571 — ASTRA 300
- K062913 — ASTRAGUARD PULMONARY FUNCTION FILTER
- K061283 — PULMOLIFE
- K061875 — MINISPIR; SPIROLAB III
- K061712 — SPIROBANK II
- K052140 — SPIROLAB, SPIROLAB II
- K052176 — FLOWHANDY ZAN100 USB
- K051572 — KOKO LEGEND
- K052158 — WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE
- K051712 — MODEL 2800 PFT FILTER
- K042758 — POLYTECH PULMONARY FUNCTION FILTER
- K043528 — SPIROTEL
- K050424 — ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50
- K042595 — SPIRO'AIR
- K042058 — ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN
- K033518 — LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 103
- K033939 — FLOSENSE II, MODEL 29-8040
- K031643 — SPIROTEL, MODEL 29-1020
- K031102 — MICROLAB SPIROMETER
- K030917 — GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130
- K020102 — IQTEQ SPIROMETER
- K030464 — GEM, MODEL 004110
- K023225 — PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE
- K021200 — COMPAS
- K022276 — KOKOMATE
- K022103 — PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM
- K020280 — PULMOLAB EX671 EXERCISE TESTING SYSTEM
- K020004 — CLINDATALINK VERSION 1.0 FOR SPIROMETRY
- K013123 — EMS PULMONARY FUNCTION TESTING FILTER
- K010761 — SPL-50 SPIROLYSER
- K013812 — SPIROLAB II, MODEL 29
- K013752 — COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM)
- K011470 — SDI SB OFFICE, MODEL 29-
- K001528 — PC FLOW +
- K001278 — SENSAIRE DIAGNOSTIC SPIROMETER
- K002499 — BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE
Data sourced from openFDA. This site is unofficial and independent of the FDA.