BWF · Class II · 21 CFR 868.5690

FDA Product Code BWF: Spirometer, Therapeutic (incentive)

Leading manufacturers include Dhd Medical Products Div. Diemolding Corp., Airlife, Inc. and Trudell Medical International.

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 Jun 01, 1999
VITAL PEP
K984468
Vital Signs, Inc.
Anesthesiology · 167d
Cleared Aug 06, 1985
AIRLIFE ELECTRONIC INCENTIVE SPIROMETER
K851334
American Pharmaseal Div. Ahsc
Anesthesiology · 127d
Cleared Aug 27, 1984
ELECATH INFANT ARTERIAL & VENOUS CANNU
K842369
Electro-Catheter Corp.
Anesthesiology · 73d
Cleared Mar 05, 1984
VOFLEX
K840239
Dhd Medical Products Div. Diemolding Corp.
Anesthesiology · 45d
Cleared Nov 28, 1983
VOLUREX II
K833337
Dhd Medical Products Div. Diemolding Corp.
Anesthesiology · 62d
Cleared Jun 03, 1983
INSPIRATORY RESISTOR KIT
K831142
Dhd Medical Products Div. Diemolding Corp.
Anesthesiology · 57d
Cleared Sep 24, 1982
BE#6006 VAR. RESIS. INSPIR. MUSCLE
K821492
Instrumentation Industries, Inc.
Anesthesiology · 129d
Cleared Feb 28, 1980
ARGYLE TRU-VOL
K800386
Sherwood Medical Co.
Anesthesiology · 6d
Cleared Nov 27, 1979
MODEL TM2-BEHIND-THE-EAR TINNITUS
K792214
Starkey Laboratories, Inc.
Anesthesiology · 25d
Cleared Nov 27, 1979
AIR INCENTIVE SPIROMETER, W/NEBULIZER
K792217
Airlife, Inc.
Anesthesiology · 22d
Cleared Oct 01, 1979
MOTIVATOR
K791842
Puritan Bennett Corp.
Anesthesiology · 12d
Cleared Sep 26, 1979
AIR INCENTIVE SPIROMETER
K791819
Airlife, Inc.
Anesthesiology · 12d
Cleared Jun 13, 1979
VOLUREX TM
K791015
Dhd Medical Products Div. Diemolding Corp.
Anesthesiology · 12d

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 →