BWF · Class II · 21 CFR 868.5690

FDA Product Code BWF: Spirometer, Therapeutic (incentive)

Leading manufacturers include Dhd Medical Products Div. Diemolding Corp., Dhd Healthcare Corp. and Chesebrough-Pond'S U.S.A. Co..

108
Total
108
Cleared
121d
Avg days
1976
Since
Declining activity - 1 submissions in the last 2 years vs 4 in the prior period
Review times increasing: avg 482d recently vs 118d historically

FDA 510(k) Cleared Spirometer, Therapeutic (incentive) Devices (Product Code BWF)

108 devices
1–24 of 108
Cleared Aug 21, 2025
InSee
K241152
Tidal Medical Technologies, LLC
Anesthesiology · 482d
Cleared Feb 02, 2024
AllPEP
K233855
Enchant Tek Co. , Ltd.
Anesthesiology · 59d
Cleared Jul 05, 2023
LungTrainer (MD2 & MD3)
K221058
Lung Trainers, LLC
Anesthesiology · 450d
Cleared Jun 02, 2023
Breathe+
K222018
Peep Medical, LLC Dba Go2 Devices
Anesthesiology · 329d
Cleared Oct 25, 2022
Hudson RCI Triflo II Incentive Deep Breathing Exerciser
K220565
Medline Industries, Inc.
Anesthesiology · 239d
Cleared Mar 31, 2021
Pulsehaler
K203378
Respinova, Ltd.
Anesthesiology · 134d
Cleared Feb 19, 2020
D R Burton OxyPAP
K192000
D R Burton Healthcare, LLC
Anesthesiology · 208d
Cleared Oct 24, 2019
Acapella Choice Blue Vibratory PEP Device
K181660
Smiths Medical
Anesthesiology · 486d
Cleared Aug 16, 2019
Combined Aerobika OPEP and VersaPAP device
K183108
Trudell Medical International
Anesthesiology · 281d
Cleared Jul 01, 2019
Hudson RCI Voldyne Volumetric Exerciser
K182847
Teleflexmedical, Inc.
Anesthesiology · 265d
Cleared Aug 17, 2018
VersaPAP Positive Airway Pressure (PAP) Device
K173918
Trudell Medical International
Anesthesiology · 238d
Cleared Dec 22, 2017
VPOD ITPR
K172388
Advanced Circulatory System, A Wholly Owned Subsidiary OF
Anesthesiology · 136d
Cleared Feb 23, 2017
MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM
K160837
Medinet Srl
Anesthesiology · 335d
Cleared Feb 21, 2017
VibraPEP
K163091
Medica Holdings, LLC
Anesthesiology · 109d
Cleared Aug 03, 2016
iPEP System and vPEP
K160636
D R Burton Healthcare, LLC
Anesthesiology · 149d
Cleared May 27, 2016
O-PEP
K150044
Pari Respiratory Equipment, Inc.
Anesthesiology · 501d
Cleared Mar 25, 2016
VibraPEP
K153441
Medica Holdings, LLC
Anesthesiology · 119d
Cleared Oct 15, 2015
Aerobika OPEP Devive with Manometer
K150173
Trudell Medical International
Anesthesiology · 262d
Cleared Dec 19, 2014
AEROSURE MEDIC
K140772
Actegy , Ltd.
Anesthesiology · 267d
Cleared Sep 03, 2014
VOLUMETRIC INCENTIVE SPIROMETER
K141355
Besmed Health Business Corporation
Anesthesiology · 103d
Cleared Apr 04, 2014
TRIBALL INCENTIVE SPIROMETER
K133873
Besmed Health Business Corp
Anesthesiology · 105d
Cleared May 16, 2013
AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE
K123400
Trudell Medical Intl.
Anesthesiology · 192d
Cleared Jun 08, 2000
TRI-BALL
K994074
Leventon, S.A.
Anesthesiology · 189d
Cleared Apr 12, 2000
INCENTIVE SPIROMETER
K000314
Engineered Medical Systems
Anesthesiology · 71d

About Product Code BWF - Regulatory Context

510(k) Submission Activity

108 total 510(k) submissions under product code BWF since 1976, with 108 receiving FDA clearance (average review time: 121 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 4 in the prior period.

FDA 510(k) Review Time - BWF Product Code

Recent submissions under BWF have taken an average of 482 days to reach a decision - up from 118 days historically. Manufacturers should account for longer review timelines in current project planning.

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