Product code BWF— Anesthesiology
INCENTIVE SPIROMETER
- Classification name
- Spirometer, Therapeutic (Incentive)
- Device class
- Class 2
- Regulation
- 21 CFR 868.5690
- Advisory panel
- Anesthesiology
- Total cleared
- 108
- First cleared
- Most recent
Market context for product code BWF
FDA has cleared devices under product code BWF between 1976 and 2025, filed by 76 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- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2010
- 2009
Top applicants under product code BWF
Recent clearances under product code BWF
1–100 of 108- K241152 — InSee
- K233855 — AllPEP
- K221058 — LungTrainer (MD2 & MD3)
- K222018 — Breathe+
- K220565 — Hudson RCI Triflo II Incentive Deep Breathing Exerciser
- K203378 — Pulsehaler
- K192000 — D R Burton OxyPAP
- K181660 — Acapella Choice Blue Vibratory PEP Device
- K183108 — Combined Aerobika OPEP and VersaPAP device
- K182847 — Hudson RCI Voldyne Volumetric Exerciser
- K173918 — VersaPAP Positive Airway Pressure (PAP) Device
- K172388 — VPOD ITPR
- K160837 — MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM
- K163091 — VibraPEP
- K160636 — iPEP System and vPEP
- K150044 — O-PEP
- K153441 — VibraPEP
- K150173 — Aerobika OPEP Devive with Manometer
- K140772 — AEROSURE MEDIC
- K141355 — VOLUMETRIC INCENTIVE SPIROMETER
- K133873 — TRIBALL INCENTIVE SPIROMETER
- K123400 — AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE
- K091557 — LUNG FLUTE THERAPEUTIC
- K090829 — PARI PEP S
- K080299 — RESPIFIT S, MODEL RS-LR1001004
- K070490 — CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR)
- K053149 — SPIRO-BALL
- K040084 — LIFESTYLE CIRCULATORY ENHANCER
- K033401 — MODIFICATION TO RESQPOD CIRCULATORY ENHANCER
- K022906 — RESQPOD CIRCULATORY ENHANCER
- K012368 — AEROPEP
- K002768 — ACAPELLA
- K003146 — CLINIFLO INCENTIVE SPIROMETER
- K994074 — TRI-BALL
- K000314 — INCENTIVE SPIROMETER
- K992256 — FROLOV'S RESPIRATION TRAINING DEVICE, FRTD-01
- K991561 — ROADRUNNER, PEP THERAPY DEVICE
- K991300 — BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE
- K983308 — RC CORNET, MODEL #44F50
- K984468 — VITAL PEP
- K983467 — THERAPEP
- K974848 — MINI-CISER
- K972824 — THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER
- K972042 — PARI PEP THERAPY SYSTEM
- K970596 — DHD EMERALD PRODUCT
- K954492 — MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX
- K962749 — THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT
- K961077 — PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE
- K953055 — MISTASSIST BREATHING EXERCISER
- K944412 — THE BREATHER
- K944344 — LUNG TECHNOLOGIES 5000 THERAPEUTIC INCENTIVE SPIROMETER
- K945118 — EXPIRATORY BREATHING EXERCISER
- K944900 — THERAPEP
- K942919 — MERCURY EXPIRATORY RESISTANCE EXERCISER
- K912943 — THRESHOLD 2X INSPIRATORY MUSCLE TRAINER
- K910138 — TVS II ELECTRONIC INCENTIVE SPIROMETER
- K903489 — THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000
- K900754 — RESPIREX 2
- K893665 — AEROSOL INHALATION MONITOR
- K873540 — AEROBICA - LUNG EXERCISER
- K873579 — AMBU RMT VALVE
- K871904 — TOTAL LUNG EXERCISER (TLE)
- K871742 — MODIFIED USE OF PLEX INSPIRATORY MUSCLE TRAINER
- K870514 — THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER
- K864719 — PFLEX EM(TM) (EXERCISE MONITOR)
- K861564 — THE LUNG GYM (XLATOR AND NLATOR)
- K851334 — AIRLIFE ELECTRONIC INCENTIVE SPIROMETER
- K844963 — VITAPEP
- K842369 — ELECATH INFANT ARTERIAL & VENOUS CANNU
- K842634 — PFLEX RESPIRATORY MUSCLE EXERCISER
- K840239 — VOFLEX
- K840418 — INSPIRATORY/EXPIRATORY MUSCLE EXERCIS
- K833337 — VOLUREX II
- K833012 — INSPIROMETER
- K832878 — GOAL TENDER
- K831142 — INSPIRATORY RESISTOR KIT
- K821492 — BE#6006 VAR. RESIS. INSPIR. MUSCLE
- K822359 — SPI-RISE
- K821998 — RESPICORD
- K820528 — PFLEX TM
- K820606 — MONAGHAN'S TRUE VOLUME EXERCISER
- K813476 — OHIO VOLUME INCENTIVE SPIROMETER
- K810641 — K-MED ENCOURAGER INCENTIVE SPIROMETER
- K801199 — VOLDYNE VOLUMETRIC INCENTIVE DEEP BR. EX
- K800546 — BUNN VOLUMAIRE RESPIRATORY EXERCISER
- K800386 — ARGYLE TRU-VOL
- K792598 — DISPOSABLE INCENTIVE SPIROMETER
- K792571 — COUNTER UNIT
- K792214 — MODEL TM2-BEHIND-THE-EAR TINNITUS
- K792217 — AIR INCENTIVE SPIROMETER, W/NEBULIZER
- K791842 — MOTIVATOR
- K791819 — AIR INCENTIVE SPIROMETER
- K791015 — VOLUREX TM
- K790744 — LUNG FUNCTION AMPLIFIER EXERCISER
- K781831 — SPIROMETER, INCENTIVE CATALOG # 1750
- K782016 — SPIROCARE 108-B
- K781731 — INCENT-O-NEB
- K781838 — CALCULATOR, WITH CHARGER
- K781833 — EXERCISER, AIR-EZE INCENTIVE
- K781669 — RESPIRATORY EXERCISOR, VOLUME PULSE
Data sourced from openFDA. This site is unofficial and independent of the FDA.