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Data / Medical devices / Bronchoscope Accessory

Bronchoscope Accessory (KTI): 36 FDA-registered makers in 12 countries

36 establishments in 12 countries are registered with the FDA to make Bronchoscope Accessory (product code KTI, Class 2, 21 CFR 874.4680). 26 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 34 510(k) clearances under this code, the latest on July 24, 2026, and lists 6 recall events (1 Class I). FDA data exported November 2, 2026.

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Product code
KTI
Device class
2
Regulation
874.4680
Medical specialty
Ear, Nose, Throat

Makers by country

CountryMakers
United States18
China5
Japan2
Ireland2
Costa Rica2
South Africa1
South Korea1
Hong Kong1
Vietnam1
Mexico1
Pakistan1
Germany1

Makers of Bronchoscope Accessory

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
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Manufacturer3March 18, 2020000api.fda.gov
Olympus Medical Systems Corp.HACHIOJI-SHI Tokyo, JapanSpecification developer3July 29, 2025000api.fda.gov
AOMORI OLYMPUS CO., LTD. Kuroishi SiteKUROISHI-SHI Aomori, JapanManufacturer2March 31, 2025000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer2June 23, 2017000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer2June 23, 2017000api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer2June 23, 2017000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer2March 8, 2022000api.fda.gov
Acclarent, Inc.Irvine, CA, United StatesSpecification developer1March 31, 2011020api.fda.gov
Alton Shanghai Medical Instruments Co LtdShanghai, ChinaComplaint file establishment, Manufacturer1March 4, 2025000api.fda.gov
Atrion Medical Products, Inc.Arab, AL, United StatesContract manufacturer, Manufacturer1June 12, 2009000api.fda.gov
Bryan Medical Inc.Cincinnati, OH, United StatesSpecification developer1June 25, 2015010api.fda.gov
Boston Scientific CorporationEl Coyol Alajuela, Costa RicaManufacturer1April 5, 2002000api.fda.gov
Boston Scientific LimitedCORK Munster, IrelandManufacturer1June 23, 2017000api.fda.gov
Conmed CorporationWestborough, MA, United StatesSpecification developer1April 25, 1984000api.fda.gov
Disa Medinotec (pty) LtdNorthriding, Johannesburg Gauteng, South AfricaManufacturer1November 24, 2021000api.fda.gov
Dongguan TT Medical, Inc.Dongguan Guangdong, ChinaManufacturer1March 1, 2023000api.fda.gov
FinemedixDaegu Gwangyeogsi, South KoreaManufacturer1April 16, 2026000api.fda.gov
Ga Health Company LimitedHong Kong, Hong KongComplaint file establishment, Exporter to the US, Specification developer1May 11, 2023000api.fda.gov
Gyrus Acmi, Inc.Westborough, MA, United StatesSpecification developer1March 18, 2020000api.fda.gov
Intuit Medical Products, LLCLawrenceville, GA, United StatesSpecification developer1July 27, 2016000api.fda.gov
Leadoptik Inc.San Jose, CA, United StatesManufacturer1December 19, 2025000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.Nanjing Jiangsu, ChinaManufacturer1July 20, 2022000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.NAN JING Jiangsu, ChinaManufacturer1July 20, 2022000api.fda.gov
Olympus Vietnam Co. Ltd.Dong Nai City, VietnamManufacturer1July 29, 2025000api.fda.gov
Praxis Medical LLCTampa, FL, United StatesSpecification developer1September 25, 2023000api.fda.gov
Serpex Medical, Inc.Santa Clara, CA, United StatesComplaint file establishment, Specification developer1October 8, 2025000api.fda.gov
Biomerics AlajuelaAlajuela, Costa RicaContract manufacturer0000api.fda.gov
Centerpoint Systems LLCWest Valley City, UT, United StatesContract manufacturer0000api.fda.gov
Consolidated Medical Equipment CompanyChihuahua, MexicoContract manufacturer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesManufacturer for export0000api.fda.gov
Qsa Surgical (pvt) Ltd.SIALKOT Punjab, PakistanContract manufacturer0000api.fda.gov
Quadrant Technologies, LLCGrayslake, IL, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer0010api.fda.gov
Resolution MedicalMinneapolis, MN, United StatesContract manufacturer0000api.fda.gov
Smartdata Suzhou Co., LtdSuzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov

Updated July 24, 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.