Skip to the page

Data / Medical devices / Pump, Portable, Aspiration (Manual Or Powered)

Pump, Portable, Aspiration (Manual Or Powered) (BTA): 72 FDA-registered makers in 16 countries

72 establishments in 16 countries are registered with the FDA to make Pump, Portable, Aspiration (Manual Or Powered) (product code BTA, Class 2, 21 CFR 878.4780). 48 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 160 510(k) clearances under this code, the latest on October 7, 2026, and lists 14 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.

Product code
BTA
Device class
2
Regulation
878.4780
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States28
China12
Germany9
Switzerland5
Taiwan4
Canada3
Mexico2
Thailand1
Spain1
Hong Kong1
Norway1
Morocco1
Costa Rica1
Tunisia1
Monaco1
Lithuania1

Makers of Pump, Portable, Aspiration (Manual Or Powered)

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
Medela AGBAAR Zug, SwitzerlandComplaint file establishment, Manufacturer9May 18, 2016010api.fda.gov
Ohio Medical LLCGurnee, IL, United StatesComplaint file establishment, Manufacturer4April 27, 2010040api.fda.gov
Sscor, Inc.Simi Valley, CA, United StatesManufacturer4May 18, 2004010api.fda.gov
Atmos Medizintechnik GMBH & Co. KGLENZKIRCH Baden-Wurttemberg, GermanyManufacturer3March 7, 2025000api.fda.gov
Shenzhen Kingboom Technology Co., LtdShenzhen Guangdong, ChinaManufacturer3May 12, 2026000api.fda.gov
Shenzhen Root Innovation Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer3May 26, 2026000api.fda.gov
Avita Corp (thailand) Co., Ltd.Chonburi Chon Buri, ThailandManufacturer2December 31, 2024000api.fda.gov
Avita CorporationSan-Chung District, New Taipei City, TaiwanManufacturer, Specification developer2December 31, 2024000api.fda.gov
Allied Medical LLCEarth City, MO, United StatesManufacturer, Specification developer2August 21, 1995000api.fda.gov
Geon CorporationCHANG HWA HSIEN Changhua, TaiwanManufacturer2February 4, 2025000api.fda.gov
Karl Storz Endoscopy-America, Inc.Auburn, MA, United StatesContract manufacturer, Repackager or relabeler2August 12, 1998000api.fda.gov
Laerdal Medical (suzhou) Co., Ltd.215009 Suzhou Jiangsu Province, ChinaManufacturer2December 20, 1999000api.fda.gov
Medgyn Products, Inc.Westmont, IL, United StatesManufacturer, Repackager or relabeler2June 8, 2001000api.fda.gov
Precision Medical, Inc.Northampton, PA, United StatesManufacturer2April 1, 1998010api.fda.gov
Shenzhen Desida Technology Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer, Manufacturer2May 16, 2025000api.fda.gov
Ardo Medical AGUNTERAEGERI Zug, SwitzerlandManufacturer1June 8, 2001000api.fda.gov
Avita (wujiang) Co., LtdWujiang City Jiangsu, ChinaContract manufacturer, Manufacturer1May 26, 2010000api.fda.gov
Anest Iwata Sparmax Co., Ltd.Dacun Changhua, TaiwanManufacturer1September 3, 2020000api.fda.gov
Centese, Inc.Omaha, NE, United StatesManufacturer1November 29, 2018000api.fda.gov
DRW MedicalAston, PA, United StatesManufacturer1September 16, 2022000api.fda.gov
Gi SupplyMechanicsburg, PA, United StatesManufacturer1April 19, 2023000api.fda.gov
Haemonetics CorporationBoston, MA, United StatesSpecification developer1October 5, 2005010api.fda.gov
Hersill, S.L.MOSTOLES (MADRID) Madrid(Province), SpainManufacturer1April 27, 2010000api.fda.gov
Hong Kong Lute Technology Co., LimitedHong Kong, Hong KongManufacturer1June 6, 2025000api.fda.gov
Haemonetics Mexico Manufacturing S. de R.L. de C.V.TIJUANA, B.C. Mexico, MexicoManufacturer1October 5, 2005000api.fda.gov
Hetaida Technology Co., Ltd.Dongguan Guangdong, ChinaManufacturer1July 1, 2024000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer1August 12, 1998000api.fda.gov
Laerdal Medical AS, Stavanger ManufacturingSandnes Rogaland, NorwayManufacturer1December 20, 1999000api.fda.gov
Medco MFG.Spring, TX, United StatesManufacturer1February 12, 1999000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer1May 4, 2021000api.fda.gov
Microsurgical Technology, Inc.Redmond, WA, United StatesComplaint file establishment, Manufacturer, Specification developer1February 17, 2004000api.fda.gov
Nouvag AGGOLDACH Sankt Gallen, SwitzerlandManufacturer1December 17, 2004000api.fda.gov
Orbisana Healthcare GmbHTROISDORF North Rhine-Westphalia, GermanyManufacturer1January 28, 2002000api.fda.gov
Penumbra, Inc.Alameda, CA, United StatesManufacturer1August 17, 2005000api.fda.gov
Penumbra Inc.Roseville, CA, United StatesManufacturer1August 17, 2005000api.fda.gov
Penumbra Inc.Salt Lake City, UT, United StatesManufacturer1August 17, 2005000api.fda.gov
Penumbra Inc.Livermore, CA, United StatesManufacturer1August 17, 2005000api.fda.gov
R & D Batteries, Inc.Burnsville, MN, United StatesManufacturer1June 28, 1994000api.fda.gov
Shenzhen Dongjiang Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer1April 14, 2026000api.fda.gov
Shenzhen Hugemed Medical Technical Development Co., LtdShenzhen Guangdong, ChinaManufacturer1May 14, 2026000api.fda.gov
Simex Medizintechnik GMBHDeisslingen Baden-Wurttemberg, GermanyManufacturer1September 22, 2014000api.fda.gov
Soering GMBHQUICKBORN Schleswig-Holstein, GermanyManufacturer1September 23, 1999000api.fda.gov
Somavac Medical Solutions, Inc.Memphis, TN, United StatesManufacturer1May 31, 2018000api.fda.gov
Taidoc Technology CorporationNew Taipei City, TaiwanManufacturer1December 19, 2018000api.fda.gov
Wells Johnson Co.Tucson, AZ, United StatesManufacturer1October 20, 1983000api.fda.gov
Zhongshan A&j Medical Equipment Co., Ltd.Guangdong, ChinaManufacturer1June 26, 2007000api.fda.gov
Zhongshan GL Electronics Co.,ltdZHONGSHAN Guangdong, ChinaManufacturer1October 7, 2026000api.fda.gov
Zoll Medical CorporationChelmsford, MA, United StatesComplaint file establishment, Manufacturer1April 18, 2017000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Asskea GMBHGebesee Thuringia, GermanyContract manufacturer0000api.fda.gov
Axcesor LLCMenomonee Falls, WI, United StatesContract manufacturer0000api.fda.gov
Cro, LLCMissoula, MT, United StatesContract manufacturer0000api.fda.gov
Consolidated Medical Equipment CompanyChihuahua, MexicoContract manufacturer0000api.fda.gov
EmotechnicCasablanca, MoroccoContract manufacturer0000api.fda.gov
Gebruder Renggli, AGSchaffhausen, SwitzerlandContract manufacturer0000api.fda.gov
Isomedix Operations Inc.San Diego, CA, United StatesManufacturer for export0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGNEUHAUSEN OBECK Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Linamar Innovation HubGuelph Ontario, CanadaContract manufacturer0000api.fda.gov
MicroVention Costa Rica S.R.L.. Alajuela, Costa RicaContract manufacturer0000api.fda.gov
MicroVention, Inc.Aliso Viejo, CA, United StatesSpecification developer0000api.fda.gov
O-Two Medical Technologies, Inc.Brampton Ontario, CanadaManufacturer0000api.fda.gov
PromedtechFouchena Tunis, TunisiaContract manufacturer0000api.fda.gov
Promepla S.A.MMONACO Monaco-Ville, MonacoContract manufacturer0000api.fda.gov
Shenzhen Bi-Rich Medical Devices Co., LtdShenzhen City Guangdong, ChinaContract manufacturer0000api.fda.gov
Storz Endoskop Produktions GMBHSchaffhausen, SwitzerlandContract manufacturer0000api.fda.gov
Sedation Systems LLCTierra Verde, FL, United StatesSpecification developer0000api.fda.gov
Thornhill Research Inc.TORONTO Ontario, CanadaComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
UAB KitronKAUNAS Kauno Apskritis, LithuaniaContract manufacturer0000api.fda.gov
Ventec Life Systems, Inc.Woodinville, WA, United StatesManufacturer0000api.fda.gov
Ventec Life Systems, Inc.Bothell, WA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Vincent Medical (dong Guan) Manufacturing Co., Ltd.Dong Guan City Guangdong, ChinaContract manufacturer0000api.fda.gov

Updated October 7, 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.