Skip to the page
Get started free

Data / Medical devices / Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type (KFM): 18 FDA-registered makers in 7 countries

18 establishments in 7 countries are registered with the FDA to make Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type (product code KFM, Class 2, 21 CFR 870.4360). 12 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 84 510(k) clearances under this code, the latest on August 4, 2025, and lists 23 recall events (1 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
KFM
Device class
2
Regulation
870.4360
Medical specialty
Cardiovascular

Makers by country

CountryMakers
United States8
Germany3
Italy2
Japan2
Mexico1
Switzerland1
United Kingdom1

Makers of Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Medtronic Perfusion SystemsMinneapolis, MN, United StatesManufacturer, Specification developer7August 27, 2019000api.fda.gov
Medtronic Mexico S. de R.L. de CVTijuana Baja California, MexicoManufacturer7August 27, 2019000api.fda.gov
Spectrum Medical SRLMirandola Modena, ItalyManufacturer6August 4, 2025010api.fda.gov
Ashitaka Factory Of Terumo Corp.FUJINOMIYA Shizuoka, JapanManufacturer3April 17, 2008000api.fda.gov
Sorin Group Italia S.R.LMIRANDOLA Modena, ItalyManufacturer3August 7, 2019000api.fda.gov
MAQUET CARDIOPULMONARY GmbHHechingen Baden-Wurttemberg, GermanyManufacturer2September 12, 2008000api.fda.gov
Terumo Cardiovascular Systems CorporationElkton, MD, United StatesManufacturer2November 18, 2021030api.fda.gov
Terumo Cardiovascular Systems CorporationAnn Arbor, MI, United StatesManufacturer2July 13, 1990050api.fda.gov
Thoratec Corp.Pleasanton, CA, United StatesManufacturer2October 8, 2009000api.fda.gov
Thoratec Switzerland GMBHZurich, SwitzerlandManufacturer2October 8, 2009021api.fda.gov
MAQUET CARDIOPULMONARY GmbHRastatt Baden-Wurttemberg, GermanySpecification developer1August 31, 2000000api.fda.gov
Thoratec CorporationSan Ramon, CA, United StatesManufacturer1March 25, 2003000api.fda.gov
Breethe, Inc.Halethorpe, MD, United StatesManufacturer0000api.fda.gov
Kluge Design Inc.Rogers, MN, United StatesContract manufacturer0000api.fda.gov
KYOCERA Medical Corporation Shiga Yasu PlantYasu-shi Shiga, JapanContract manufacturer0000api.fda.gov
Medikomp GMBHRastatt Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Spectrum Medical LtdGLOUCESTER Gloucestershire, United KingdomManufacturer0000api.fda.gov
Sterilization Services Of VirginiaRichmond, VA, United StatesContract manufacturer0000api.fda.gov

Updated August 4, 2025. 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.