FDA.reportPublic FDA data

Incentive spirometer

Definition
A hand-held, mechanical, breathing-muscle exerciser intended to be used in respiratory therapy to encourage and motivate deep-breathing manoeuvres, typically for the postsurgical treatment and prevention of atelectasis (lung collapse) and to help facilitate airway opening and clearing. It includes an indicator in a housing that rises in relation to patient inspiratory effort, performed via an attached tube and mouthpiece, to determine the maximum volume of gas which can be inspired [i.e., the inspiratory vital capacity (IVC)]. This is a single-patient device designed for use in a medical facility and in the home. This is a reusable device.
GUDID devices
149
Last updated
2026-06-06 06:07:35

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04719882305610MaxiPEPENCHANT TEK. CO, LTD.032-10-301U2026-05-28
00607411600074N/ASALTER LABS6600-0-252016-09-24
00818323020915VIVEVIVE HEALTH LLCRHB10352019-03-14
00840117320918Resp-O2 Volumetric Incentive Spirometers 5000 mLDynarex Corporation361012021-04-22
00840117320925Resp-O2 Incentive Spirometer. Tri-Flow ChamberDynarex Corporation361022021-04-22
00851232007011vPEP OPEP DEVICED R BURTON HEALTHCARE, LLC12017-01-27
00851232007028vPEP-HCD R BURTON HEALTHCARE, LLC12018-10-24
00851232007080vPEP-HC OPEP DEVICE WITH T-PIECE ADAPTERD R BURTON HEALTHCARE, LLC12026-04-28
00851232007127vPEPD R BURTON HEALTHCARE, LLC12026-04-28
00851232007530iPEPD R BURTON HEALTHCARE, LLC12018-01-02
00851232007554PocketPEP AdvantageD R BURTON HEALTHCARE, LLC12021-07-01
00851232007578PocketPEPD R BURTON HEALTHCARE, LLC12018-01-02
00851232007585PocketPEP OPEP DEVICE w/ T-PIECE ADAPTER & MOUTHPIECED R BURTON HEALTHCARE, LLC12026-04-28
00851232007684PocketPEP with OxyJETD R BURTON HEALTHCARE, LLC12020-04-10
00851232007721PocketPEP Advantage with OxyJETD R BURTON HEALTHCARE, LLC12020-04-10
00860006377830Pure Comfort Breath ExerciserHOME AIDE DIAGNOSTICS, INC.78302024-10-08
04026704390519HUDSON RCITELEFLEX INCORPORATEDIPN0444692016-09-16
04026704391813HUDSON RCITELEFLEX INCORPORATEDIPN0455402016-09-16
04026704391820HUDSON RCITELEFLEX INCORPORATEDIPN0455442016-09-16
04026704391837HUDSON RCITELEFLEX INCORPORATEDIPN0455452016-09-16
04026704595532HUDSON RCITELEFLEX INCORPORATEDIPN0427692016-09-16
04026704596973HUDSON RCITELEFLEX INCORPORATEDIPN0455382016-09-16
04026704596980HUDSON RCITELEFLEX INCORPORATEDIPN0455392016-09-16
04026704596997HUDSON RCITELEFLEX INCORPORATEDIPN0455412016-09-16
04026704597000HUDSON RCITELEFLEX INCORPORATEDIPN0455422016-09-16
04026704597017HUDSON RCITELEFLEX INCORPORATEDIPN0455432016-09-16
08018294018009AirFeel IMTFLAEM NUOVA SPAP0124EM2026-02-18
08436020761836TRI-BALLLEVENTON SAUL259120002017-06-12
08436020761843SPIRO-BALLLEVENTON SAUL259130002017-06-12
10190752117167AirLife™AIRLIFE001905A2021-04-02
10190752117716AirLife™AIRLIFERESOC4909A2021-05-07
10190752131064AirLifeAIRLIFE001902A2020-01-31
10190752131071AirLife™AIRLIFE001904A2021-03-26
10190752145573AirLife™VYAIRE MEDICAL, INC.0019002020-02-04
10197344007691HUDSON RCIMEDLINE INDUSTRIES, INC.HUD7173012023-12-18
10197344010332HUDSON RCIMEDLINE INDUSTRIES, INC.HUD88847190122026-01-23
10197344010349HUDSON RCIMEDLINE INDUSTRIES, INC.HUD88847190112026-01-23
10197344010356HUDSON RCIMEDLINE INDUSTRIES, INC.HUD88847190102026-01-23
10197344097715HUDSON RCIMEDLINE INDUSTRIES, INC.HUD17502025-07-23
10351688404008PortexICU MEDICAL, INC.0020002016-10-05
10612479269900McKessonMCKESSON MEDICAL-SURGICAL INC.16-VOL50002024-05-14
10612479269924McKessonMCKESSON MEDICAL-SURGICAL INC.16-VOL25002024-05-14
10612479269948McKessonMCKESSON MEDICAL-SURGICAL INC.16-DTFLOW2024-05-14
10641043370018ResistexMERCURY ENTERPRISES, INC.10-370012016-03-02
10788942200043PortexICU MEDICAL, INC.20-00042016-10-11
10788942200050PortexICU MEDICAL, INC.20-00052016-10-11
10788942200104PortexICU MEDICAL, INC.20-00102016-10-11
10788942200227PortexICU MEDICAL, INC.20-00222016-10-11
10788942201200PortexICU MEDICAL, INC.20-01202016-10-11
10788942211100PortexICU MEDICAL, INC.20-11102016-10-11
10788942211124PortexICU MEDICAL, INC.20-11122016-10-11
10788942212008PortexICU MEDICAL, INC.22-12002016-10-11
10788942220003MedexICU MEDICAL, INC.22-20002016-10-11
10788942225008PortexICU MEDICAL, INC.22-25002016-10-11
10788942225015PortexICU MEDICAL, INC.22-25012016-10-11
10788942231153PortexICU MEDICAL, INC.20-31152016-10-11
10788942240001PortexICU MEDICAL, INC.22-40002016-10-11
10788942240018PortexICU MEDICAL, INC.22-40012016-10-11
10788942251151PortexICU MEDICAL, INC.20-51152016-10-11
10788942271159PortexICU MEDICAL, INC.20-71152016-10-11
10801902124637HUDSON RCITELEFLEX INCORPORATEDIPN0468642016-09-16
10885403006388AirLifeCarefusion Corporation0019002016-09-01
10885403131417AirLifeCarefusion Corporation001904A2016-09-01
10885403138171AirLifeCarefusion Corporation001902A2016-09-01
10885403169069AirLifeCarefusion Corporation001901A2016-09-01
10885403169342AirLifeCarefusion Corporation001905A2016-09-01
10885403169359AirLifeCarefusion Corporation001903A2016-09-01
10885403170430AirLifeCarefusion Corporation0018122016-09-01
10885403184369AirLifeCarefusion CorporationRESOC4909A2016-09-01
10888277409149MedlineMEDLINE INDUSTRIES, INC.HCS932502022-06-10
10888277409156MedlineMEDLINE INDUSTRIES, INC.HCS935002022-06-10
10889483570814AirLife™AIRLIFE001902A2025-02-11
10889483570838AirLife™AIRLIFE001904A2025-02-11
10889483570845AirLife™AIRLIFE001905A2025-02-11
10889483642313AirLife™SUNMED, LLC001902A-CE2025-07-31
10889483642320AirLife™SUNMED, LLC001904A-CE2025-07-31
14026704615213HUDSON RCITELEFLEX INCORPORATEDIPN0491002021-01-14
14026704615220HUDSON RCITELEFLEX INCORPORATEDIPN0491012021-01-14
14026704615237HUDSON RCITELEFLEX INCORPORATEDIPN0491022021-01-14
14026704615251HUDSON RCITELEFLEX INCORPORATEDIPN0491042021-09-22