BWF — Spirometer, Therapeutic (Incentive) Class II

FDA Device Classification

Classification Details

Product Code
BWF
Device Class
Class II
Regulation Number
868.5690
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K241152tidal medical technologiesInSeeAugust 21, 2025
K233855enchant tek co.AllPEPFebruary 2, 2024
K221058lung trainersLungTrainer (MD2 & MD3)July 5, 2023
K222018peep medical, llc dba go2 devicesBreathe+June 2, 2023
K220565medline industriesHudson RCI Triflo II Incentive Deep Breathing ExerciserOctober 25, 2022
K203378respinovaPulsehalerMarch 31, 2021
K192000d r burton healthcareD R Burton OxyPAPFebruary 19, 2020
K181660smiths medicalAcapella Choice Blue Vibratory PEP DeviceOctober 24, 2019
K183108trudell medical internationalCombined Aerobika OPEP and VersaPAP deviceAugust 16, 2019
K182847teleflexmedicalHudson RCI Voldyne Volumetric ExerciserJuly 1, 2019
K173918trudell medical internationalVersaPAP Positive Airway Pressure (PAP) DeviceAugust 17, 2018
K172388advanced circulatory system, a wholly owned subsidiary ofVPOD ITPRDecember 22, 2017
K160837medinetMEDINET INCENTIVE SPIROMETERS - RESPIPROGRAMFebruary 23, 2017
K163091medica holdingsVibraPEPFebruary 21, 2017
K160636d r burton healthcareiPEP System and vPEPAugust 3, 2016
K150044pari respiratory equipmentO-PEPMay 27, 2016
K153441medica holdingsVibraPEPMarch 25, 2016
K150173trudell medical internationalAerobika OPEP Devive with ManometerOctober 15, 2015
K140772actegyAEROSURE MEDICDecember 19, 2014
K141355besmed health business corporationVOLUMETRIC INCENTIVE SPIROMETERSeptember 3, 2014