Product code BZH— Anesthesiology
PEAK FLOW METER
- Classification name
- Meter, Peak Flow, Spirometry
- Device class
- Class 2
- Regulation
- 21 CFR 868.1860
- Advisory panel
- Anesthesiology
- Total cleared
- 81
- First cleared
- Most recent
Market context for product code BZH
FDA has cleared devices under product code BZH between 1977 and 2026, filed by 55 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
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2014
- 2013
- 2010
- 2009
- 2006
- 2005
Top applicants under product code BZH
Recent clearances under product code BZH
- K253180 — Microlife Digital Peak Flow Meter, Model PF200B (PF200B)
- K252802 — Peak Flow Meter (PF-10(BR-PEF231))
- K241338 — Peak Flow Meter
- K232588 — Aluna 2
- K230423 — Electronic Peak Flow Meter
- K222810 — TD-7301 Peak Flow meter
- K203196 — Peak flow meter
- K200832 — Safey Peak Flow Meter
- K193311 — Aluna
- K191239 — Smart Peak Flow Meter
- K180487 — Peak.me
- K181666 — Smart One
- K172804 — Besmed Peak Flow Meter
- K170281 — MSA100BT Peak Flow Meter
- K152276 — Wing Smart FEVI and Peak Flow Meter
- K133975 — MSA100 PEAK FLOW METER
- K123945 — STRIVE DUAL ZONE PEAK FLOW METER
- K101380 — RXPEAKFLOW
- K092335 — PEAK EXPIRATORY FLOW METER, KN-9710
- K091412 — CLEAN PEAK FLOW METER
- K082899 — DYNAMIPEAK PEAK FLOW METER
- K053156 — MINI-WRIGHT DIGITAL, MODEL 3120001
- K050853 — PMP4 SPIROPRO
- K040723 — MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE)
- K031024 — MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100
- K030586 — MICROPEAK
- K031514 — MODIFICATION TO TRUPEAK PEAK FLOW METER
- K022124 — GALEMED PEAK FLOW METER, MODELS 3751/3752
- K023097 — TRUEZONE PEAK FLOW METER
- K013489 — KP + LFM
- K010009 — KOKO PEAK KP; KOKO PEAK KP+
- K980951 — ONEFLOW
- K991412 — VITALOGRAPH MICRO
- K992618 — RESPALERT
- K991212 — MODIFICATION TO TRUZONE PEAK FLOW METER
- K982334 — AIRZONE PEAK FLOWMETER
- K982995 — ACCUTRAX, MODEL EPF840
- K982675 — AIRWATCH II ZONELESS
- K982676 — AIRWATCH II ZONE
- K980550 — WHISTLE WATCH
- K980960 — IN-CHECK INSPIRATORY FLOWMETER
- K980443 — PEAK FLOW METER MINIMAX
- K961779 — MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER
- K970507 — PEAK FLOW METER
- K964130 — AEROGEAR ASTHMA ACTION KIT
- K962074 — VM PLUS PEAK FLOWMETER
- K963089 — TRUZONE PEAK FLOW METER
- K963095 — TRUPEAK PEAK FLOW METER
- K962924 — PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM
- K962929 — PERSONAL BEST II
- K953411 — BREATH-TAKER BREATH-ALERT
- K952713 — MINI WRIGHT LR AFS
- K952909 — AUTOZONE
- K955234 — TRUPEAK PEAK FLOW METER
- K955262 — TRUZONE PEAK FLOW METER
- K954277 — ASTECH PEAK FLOW METER
- K943678 — ELECTRONIC FLOW METER
- K953458 — RAINBOW STEP UP SYSTEMS INC. ASTHMA HOME CARE PLAN
- K934795 — CARD GUARD
- K936110 — ASPIRE
- K941226 — AIRWATCH MONITOR
- K940835 — PEAKLOG AND DISPLAY SOFTWARE
- K940836 — PEAKLOG AND DISPLAY SOFTWARE
- K924322 — FLOW=MED
- K934502 — FLOW SPIROMETER
- K933889 — PERSONAL BEST LOW RANGE
- K926307 — PEAK FLOW METER
- K924343 — WRIGHT POCKET PEAK FLOW METER
- K914126 — VMX MINI-LOG FLOWMETER
- K915060 — ASTECH HOME PEAK FLOW METER
- K920390 — THE PEAK
- K912866 — PEAK EXPIRATORY FLOW METER
- K915059 — PEAK FLOW MONITOR
- K902292 — MODIFIED ASSESS(R) PEAK FLOW METER
- K896953 — MODIFIED ASSESS(R) PEAK FLOW METER
- K853922 — PLOTTER FOR AS-500
- K851265 — PEAK FLOWMETERS FOR SPIROMETRY
- K813414 — PEAK FLOW MONITOR
- K781922 — PULMONARY MONITOR
- K781224 — METER, FLOW, PEAK
- K770580 — PEAK FLOW METER
Data sourced from openFDA. This site is unofficial and independent of the FDA.