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Data / Medical devices / Regulator, Vacuum

Regulator, Vacuum (KDP): 20 FDA-registered makers in 11 countries

20 establishments in 11 countries are registered with the FDA to make Regulator, Vacuum (product code KDP, Class 2, 21 CFR 880.6740). 2 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 21 510(k) clearances under this code, the latest on January 8, 2002, and lists 2 recall events (0 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
KDP
Device class
2
Regulation
880.6740
Medical specialty
General Hospital

Makers by country

CountryMakers
United States6
China4
India2
Taiwan1
Germany1
Canada1
Singapore1
South Korea1
United Kingdom1
Spain1
Thailand1

Makers of Regulator, Vacuum

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
Precision Medical, Inc.Northampton, PA, United StatesManufacturer2December 22, 1994000api.fda.gov
Boehringer Laboratories, LLCPhoenixville, PA, United StatesManufacturer1March 4, 1985010api.fda.gov
Acare Technology Co., Ltd.New Taipei City, TaiwanManufacturer0000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Apothecaries Sundries MFG Pvt LtdGURUGRAM Haryana, IndiaManufacturer0000api.fda.gov
Allied Medical LLCEarth City, MO, United StatesManufacturer0000api.fda.gov
Amico Patient Care CorporationRichmond Hill Ontario, CanadaManufacturer0000api.fda.gov
Bothwin Medical Technology (SG) Pte. Ltd.Singapore Central Singapore, SingaporeSpecification developer0000api.fda.gov
Curaco IncSeongnam-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
DTR Medical LtdSwansea, United KingdomManufacturer0000api.fda.gov
Gentec (shanghai) CorporationShanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hersill, S.L.MOSTOLES (MADRID) Madrid(Province), SpainManufacturer0000api.fda.gov
Hospital Equipment MFG. Co.NOIDA Uttar Pradesh, IndiaManufacturer0000api.fda.gov
J Summit Co., Ltd.Chomthong Krung Thep Maha Nakhon, ThailandContract manufacturer, Manufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
MINDRAY DS USA, Inc.Mahwah, NJ, United StatesComplaint file establishment, Contract manufacturer0000api.fda.gov
Ohio Medical LLCGurnee, IL, United StatesManufacturer0010api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Suzhou Jinsheng Plastic Co., Ltd.SUZHOU Jiangsu, ChinaContract manufacturer0000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co.,LTDSHENZHEN Guangdong, ChinaExporter to the US, Specification developer0000api.fda.gov

Updated January 8, 2002. 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.