Product Code: BWF FDA class 2 21 CFR 868.5690

Spirometer, Therapeutic (Incentive)

Anesthesiology

The Spirometer, Therapeutic (Incentive) is a device used to encourage patients to take slow, deep breaths to expand the lungs and prevent postoperative pulmonary complications such as atelectasis. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BWF, regulated under 21 CFR 868.5690 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.

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510(k)s

108

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: BWF
Device Class: FDA class 2
Regulation Number: 868.5690
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 108 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K241152	InSee	Aug 21, 2025	Substantially Equivalent	Tidal Medical Technologies, LLC
K233855	AllPEP	Feb 02, 2024	Substantially Equivalent	Enchant Tek Co. , Ltd.
K221058	LungTrainer (MD2 & MD3)	Jul 05, 2023	Substantially Equivalent	Lung Trainers, LLC
K222018	Breathe+	Jun 02, 2023	Substantially Equivalent	Peep Medical, LLC Dba Go2 Devices
K220565	Hudson RCI Triflo II Incentive Deep Breathing Exerciser	Oct 25, 2022	Substantially Equivalent	Medline Industries, Inc.
K203378	Pulsehaler	Mar 31, 2021	Substantially Equivalent	Respinova, Ltd.
K192000	D R Burton OxyPAP	Feb 19, 2020	Substantially Equivalent	D R Burton Healthcare, LLC
K181660	Acapella Choice Blue Vibratory PEP Device	Oct 24, 2019	Substantially Equivalent	Smiths Medical
K183108	Combined Aerobika OPEP and VersaPAP device	Aug 16, 2019	Substantially Equivalent	Trudell Medical International
K182847	Hudson RCI Voldyne Volumetric Exerciser	Jul 01, 2019	Substantially Equivalent	Teleflexmedical, Inc.
K173918	VersaPAP Positive Airway Pressure (PAP) Device	Aug 17, 2018	Substantially Equivalent	Trudell Medical International
K172388	VPOD ITPR	Dec 22, 2017	Substantially Equivalent	Advanced Circulatory System, A Wholly Owned Subsidiary OF
K160837	MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM	Feb 23, 2017	Substantially Equivalent	Medinet Srl
K163091	VibraPEP	Feb 21, 2017	Substantially Equivalent	Medica Holdings, LLC
K160636	iPEP System and vPEP	Aug 03, 2016	Substantially Equivalent	D R Burton Healthcare, LLC
K150044	O-PEP	May 27, 2016	Substantially Equivalent	Pari Respiratory Equipment, Inc.
K153441	VibraPEP	Mar 25, 2016	Substantially Equivalent	Medica Holdings, LLC
K150173	Aerobika OPEP Devive with Manometer	Oct 15, 2015	Substantially Equivalent	Trudell Medical International
K140772	AEROSURE MEDIC	Dec 19, 2014	Substantially Equivalent	Actegy , Ltd.
K141355	VOLUMETRIC INCENTIVE SPIROMETER	Sep 03, 2014	Substantially Equivalent	Besmed Health Business Corporation
K133873	TRIBALL INCENTIVE SPIROMETER	Apr 04, 2014	Substantially Equivalent	Besmed Health Business Corp
K123400	AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE	May 16, 2013	Substantially Equivalent	Trudell Medical Intl.
K091557	LUNG FLUTE THERAPEUTIC	Jan 04, 2010	Substantially Equivalent	Medical Acoustics
K090829	PARI PEP S	Jul 21, 2009	Substantially Equivalent	Pari Respiratory Equipment, Inc.
K080299	RESPIFIT S, MODEL RS-LR1001004	Jan 13, 2009	Substantially Equivalent	Eumedics Medizintechnik Und Marketing GmbH
K070490	CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR)	Jun 20, 2007	Substantially Equivalent	Advanced Circulatory Systems, Inc.
K053149	SPIRO-BALL	Dec 13, 2005	Substantially Equivalent	Leventon, S.A.
K040084	LIFESTYLE CIRCULATORY ENHANCER	Apr 07, 2004	Substantially Equivalent	Advanced Circulatory Systems, Inc.
K033401	MODIFICATION TO RESQPOD CIRCULATORY ENHANCER	Nov 20, 2003	Substantially Equivalent	Advanced Circulatory Systems, Inc.
K022906	RESQPOD CIRCULATORY ENHANCER	Jun 11, 2003	Substantially Equivalent	Cprx, LLC
K012368	AEROPEP	Feb 12, 2002	Substantially Equivalent	Trudell Medical Intl.
K002768	ACAPELLA	Dec 05, 2000	Substantially Equivalent	Dhd Healthcare Corp.
K003146	CLINIFLO INCENTIVE SPIROMETER	Nov 21, 2000	Substantially Equivalent	Dhd Healthcare Corp.
K994074	TRI-BALL	Jun 08, 2000	Substantially Equivalent	Leventon, S.A.
K000314	INCENTIVE SPIROMETER	Apr 12, 2000	Substantially Equivalent	Engineered Medical Systems
K992256	FROLOV'S RESPIRATION TRAINING DEVICE, FRTD-01	Jan 11, 2000	Substantially Equivalent	Intercontinental New Technologies, Inc.
K991561	ROADRUNNER, PEP THERAPY DEVICE	Nov 10, 1999	Substantially Equivalent	Dhd Healthcare Corp.
K991300	BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE	Jul 12, 1999	Substantially Equivalent	Dhd Healthcare Corp.
K983308	RC CORNET, MODEL #44F50	Jun 04, 1999	Substantially Equivalent	Pari Holding Co.
K984468	VITAL PEP	Jun 01, 1999	Substantially Equivalent	Vital Signs, Inc.
K983467	THERAPEP	Apr 02, 1999	Substantially Equivalent	Dhd Healthcare Corp.
K974848	MINI-CISER	Aug 06, 1998	Substantially Equivalent	Hougen Mfg., Inc.
K972824	THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER	Apr 03, 1998	Substantially Equivalent	Pn Medical
K972042	PARI PEP THERAPY SYSTEM	Aug 05, 1997	Substantially Equivalent	Pari Holding Co.
K970596	DHD EMERALD PRODUCT	May 16, 1997	Substantially Equivalent	Dhd Diemolding Healthcare Div.
K954492	MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX	Oct 21, 1996	Substantially Equivalent	Mercury Medical
K962749	THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT	Oct 10, 1996	Substantially Equivalent	Diemolding Corp.
K961077	PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE	Jul 15, 1996	Substantially Equivalent	Healthscan Products, Inc.
K953055	MISTASSIST BREATHING EXERCISER	Feb 08, 1996	Substantially Equivalent	The Merlin Corp.
K944412	THE BREATHER	Apr 26, 1995	Substantially Equivalent	Pal Medical, Inc.
K944344	LUNG TECHNOLOGIES 5000 THERAPEUTIC INCENTIVE SPIROMETER	Feb 03, 1995	Substantially Equivalent	Lung Technologies, Inc.
K945118	EXPIRATORY BREATHING EXERCISER	Jan 13, 1995	Substantially Equivalent	Dhd Diemolding Healthcare Div.
K944900	THERAPEP	Jan 06, 1995	Substantially Equivalent	Dhd Diemolding Healthcare Div.
K942919	MERCURY EXPIRATORY RESISTANCE EXERCISER	Sep 19, 1994	Substantially Equivalent	Mercury Ent., Inc. D/B/A Mercury Medical
K912943	THRESHOLD 2X INSPIRATORY MUSCLE TRAINER	Jan 30, 1992	Substantially Equivalent	Health Products, Inc.
K910138	TVS II ELECTRONIC INCENTIVE SPIROMETER	Mar 12, 1991	Substantially Equivalent	Monaghan Medical Corp.
K903489	THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000	Dec 10, 1990	Substantially Equivalent	Pegasus Research Corp.
K900754	RESPIREX 2	Mar 15, 1990	Substantially Equivalent	Diemolding Corp.
K893665	AEROSOL INHALATION MONITOR	Aug 21, 1989	Substantially Equivalent	Vitalograph , Ltd.
K873540	AEROBICA - LUNG EXERCISER	Feb 04, 1988	Substantially Equivalent	MBA Healthcare Products, Inc.
K873579	AMBU RMT VALVE	Dec 30, 1987	Substantially Equivalent	Ambu, Inc.
K871904	TOTAL LUNG EXERCISER (TLE)	Jul 08, 1987	Substantially Equivalent	MBA Healthcare Products, Inc.
K871742	MODIFIED USE OF PLEX INSPIRATORY MUSCLE TRAINER	Jun 15, 1987	Substantially Equivalent	Health Products, Inc.
K870514	THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER	Mar 31, 1987	Substantially Equivalent	Health Products, Inc.
K864719	PFLEX EM(TM) (EXERCISE MONITOR)	Mar 16, 1987	Substantially Equivalent	Health Products, Inc.
K861564	THE LUNG GYM (XLATOR AND NLATOR)	Aug 07, 1986	Substantially Equivalent	El-Fax Company, Inc.
K851334	AIRLIFE ELECTRONIC INCENTIVE SPIROMETER	Aug 06, 1985	Substantially Equivalent	American Pharmaseal Div. Ahsc
K844963	VITAPEP	Jun 07, 1985	Substantially Equivalent	Vitalograph , Ltd.
K842369	ELECATH INFANT ARTERIAL & VENOUS CANNU	Aug 27, 1984	Substantially Equivalent	Electro-Catheter Corp.
K842634	PFLEX RESPIRATORY MUSCLE EXERCISER	Aug 10, 1984	Substantially Equivalent	Health Scan, Inc.
K840239	VOFLEX	Mar 05, 1984	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K840418	INSPIRATORY/EXPIRATORY MUSCLE EXERCIS	Feb 17, 1984	Substantially Equivalent	Inspiron Corp.
K833337	VOLUREX II	Nov 28, 1983	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K833012	INSPIROMETER	Nov 08, 1983	Substantially Equivalent	Kinetix
K832878	GOAL TENDER	Oct 14, 1983	Substantially Equivalent	Dna Medical, Inc.
K831142	INSPIRATORY RESISTOR KIT	Jun 03, 1983	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K821492	BE#6006 VAR. RESIS. INSPIR. MUSCLE	Sep 24, 1982	Substantially Equivalent	Instrumentation Industries, Inc.
K822359	SPI-RISE	Aug 27, 1982	Substantially Equivalent	Certified Respiratory Services, Inc.
K821998	RESPICORD	Jul 30, 1982	Substantially Equivalent	Novamed Products, Inc.
K820528	PFLEX TM	Mar 26, 1982	Substantially Equivalent	Health Scan, Inc.
K820606	MONAGHAN'S TRUE VOLUME EXERCISER	Mar 23, 1982	Substantially Equivalent	Monaghan Medical Corp.
K813476	OHIO VOLUME INCENTIVE SPIROMETER	Dec 31, 1981	Substantially Equivalent	Airco/Ohio Medical Products
K810641	K-MED ENCOURAGER INCENTIVE SPIROMETER	May 13, 1981	Substantially Equivalent	K-Med, Inc.
K801199	VOLDYNE VOLUMETRIC INCENTIVE DEEP BR. EX	Jun 04, 1980	Substantially Equivalent	Chesebrough-Pond'S U.S.A. Co.
K800546	BUNN VOLUMAIRE RESPIRATORY EXERCISER	Mar 25, 1980	Substantially Equivalent	The John Bunn Co.
K800386	ARGYLE TRU-VOL	Feb 28, 1980	Substantially Equivalent	Sherwood Medical Co.
K792598	DISPOSABLE INCENTIVE SPIROMETER	Jan 04, 1980	Substantially Equivalent	Hospitak, Inc.
K792571	COUNTER UNIT	Dec 19, 1979	Substantially Equivalent	Empire Plastics Manufacturer
K792217	AIR INCENTIVE SPIROMETER, W/NEBULIZER	Nov 27, 1979	Substantially Equivalent	Airlife, Inc.
K792214	MODEL TM2-BEHIND-THE-EAR TINNITUS	Nov 27, 1979	Substantially Equivalent	Starkey Laboratories, Inc.
K791842	MOTIVATOR	Oct 01, 1979	Substantially Equivalent	Puritan Bennett Corp.
K791819	AIR INCENTIVE SPIROMETER	Sep 26, 1979	Substantially Equivalent	Airlife, Inc.
K791015	VOLUREX TM	Jun 13, 1979	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K790744	LUNG FUNCTION AMPLIFIER EXERCISER	Apr 27, 1979	Substantially Equivalent	Empire Plastics Manufacturer
K781831	SPIROMETER, INCENTIVE CATALOG # 1750	Dec 15, 1978	Substantially Equivalent	Hudson Oxygen Therapy Sales Co.
K782016	SPIROCARE 108-B	Dec 13, 1978	Substantially Equivalent	Marion Laboratories, Inc.
K781731	INCENT-O-NEB	Dec 05, 1978	Substantially Equivalent	B & F Medical Products, Inc.
K781838	CALCULATOR, WITH CHARGER	Nov 21, 1978	Substantially Equivalent	C.R. Bard, Inc.
K781833	EXERCISER, AIR-EZE INCENTIVE	Nov 14, 1978	Substantially Equivalent	Chesebrough-Pond'S U.S.A. Co.
K781669	RESPIRATORY EXERCISOR, VOLUME PULSE	Oct 23, 1978	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K781245	LUNG EXER. BAG, POST-OP, MODIFIED	Sep 20, 1978	Substantially Equivalent	Dytek Corp.
K780265	FLOW REDUCING ANGULATION STAND	Mar 09, 1978	Substantially Equivalent	Chesebrough-Pond'S U.S.A. Co.
K780037	EXERCISER, RESP., DEEP BREATHING	Feb 24, 1978	Substantially Equivalent	Medical Technologies of Georgia
K771532	SPIROMETEO & LUNG EXERCISER, 4601	Aug 26, 1977	Substantially Equivalent	Boehringer Laboratories
K770619	EXERCISOR, RESPIRATORY	Apr 07, 1977	Substantially Equivalent	Cutter Laboratories, Inc.
K770141	INSPIROMETER RESPIRATORY EXERCISER	Feb 01, 1977	Substantially Equivalent	Medi, Inc.
K760762	INCENTIVE SPIROMETER	Oct 08, 1976	Substantially Equivalent	I-Spiron
K760167	BAG, POST OPERATIVE LUNG EXERCIZING BLOW	Aug 06, 1976	Substantially Equivalent	Dytek Corp.