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Data / Medical devices / Spirometer, Therapeutic (Incentive) / United States

FDA-registered makers of Spirometer, Therapeutic (Incentive) in the United States: 19 establishments

19 establishments in the United States are registered with the FDA to make Spirometer, Therapeutic (Incentive) (product code BWF). 14 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Device
Spirometer, Therapeutic (Incentive)
Product code
BWF
Country
United States

Makers of Spirometer, Therapeutic (Incentive) in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer6October 24, 2019000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer4October 25, 2022000api.fda.gov
Pari Respiratory Equipment, Inc.Midlothian, VA, United StatesManufacturer, Repackager or relabeler, Specification developer3May 27, 2016000api.fda.gov
D R Burton Healthcare, LLCFarmville, NC, United StatesManufacturer2February 19, 2020000api.fda.gov
MCSC Medical LLCOrlando, FL, United StatesComplaint file establishment, Specification developer2April 3, 1998000api.fda.gov
Monaghan Medical Corp.Plattsburgh, NY, United StatesManufacturer, Repackager or relabeler2August 17, 2018000api.fda.gov
Respironics Inc.Murrysville, PA, United StatesComplaint file establishment, Specification developer2July 15, 1996000api.fda.gov
Tri-Anim Health Services, Inc.Dublin, OH, United StatesSpecification developer2February 21, 2017000api.fda.gov
Fainteer LimitedLittleton, CO, United StatesManufacturer, Repackager or relabeler1January 13, 1995000api.fda.gov
ICU Medical, Inc.Dublin, OH, United StatesContract manufacturer, Manufacturer1October 24, 2019000api.fda.gov
Mercury Medical Enterprises, LLCClearwater, FL, United StatesManufacturer1September 19, 1994000api.fda.gov
Salter LabsEl Paso, TX, United StatesSpecification developer1April 2, 1999000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesSpecification developer1September 26, 1979000api.fda.gov
Zoll Medical CorporationChelmsford, MA, United StatesComplaint file establishment, Manufacturer, Specification developer1November 20, 2003000api.fda.gov
Bound Tree Medical, LLCGrand Prairie, TX, United StatesManufacturer0000api.fda.gov
Nortech Systems, Inc.Milaca, MN, United StatesContract manufacturer0000api.fda.gov
Prospect Life SciencesWestminster, CO, United StatesContract manufacturer0000api.fda.gov
Scientific Molding Corporation, Ltd. Dba SMC Ltd.Somerset, WI, United StatesContract manufacturer0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.