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
| Country | Makers |
|---|---|
| United States | 18 |
| China | 5 |
| Japan | 2 |
| Ireland | 2 |
| Costa Rica | 2 |
| South Africa | 1 |
| South Korea | 1 |
| Hong Kong | 1 |
| Vietnam | 1 |
| Mexico | 1 |
| Pakistan | 1 |
| Germany | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Complaint file establishment, Manufacturer | 3 | March 18, 2020 | 0 | 0 | 0 | api.fda.gov |
| Olympus Medical Systems Corp. | HACHIOJI-SHI Tokyo, Japan | Specification developer | 3 | July 29, 2025 | 0 | 0 | 0 | api.fda.gov |
| AOMORI OLYMPUS CO., LTD. Kuroishi Site | KUROISHI-SHI Aomori, Japan | Manufacturer | 2 | March 31, 2025 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Marlborough, MA, United States | Complaint file establishment, Specification developer | 2 | June 23, 2017 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 2 | June 23, 2017 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 2 | June 23, 2017 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Manufacturer | 2 | March 8, 2022 | 0 | 0 | 0 | api.fda.gov |
| Acclarent, Inc. | Irvine, CA, United States | Specification developer | 1 | March 31, 2011 | 0 | 2 | 0 | api.fda.gov |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai, China | Complaint file establishment, Manufacturer | 1 | March 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| Atrion Medical Products, Inc. | Arab, AL, United States | Contract manufacturer, Manufacturer | 1 | June 12, 2009 | 0 | 0 | 0 | api.fda.gov |
| Bryan Medical Inc. | Cincinnati, OH, United States | Specification developer | 1 | June 25, 2015 | 0 | 1 | 0 | api.fda.gov |
| Boston Scientific Corporation | El Coyol Alajuela, Costa Rica | Manufacturer | 1 | April 5, 2002 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | CORK Munster, Ireland | Manufacturer | 1 | June 23, 2017 | 0 | 0 | 0 | api.fda.gov |
| Conmed Corporation | Westborough, MA, United States | Specification developer | 1 | April 25, 1984 | 0 | 0 | 0 | api.fda.gov |
| Disa Medinotec (pty) Ltd | Northriding, Johannesburg Gauteng, South Africa | Manufacturer | 1 | November 24, 2021 | 0 | 0 | 0 | api.fda.gov |
| Dongguan TT Medical, Inc. | Dongguan Guangdong, China | Manufacturer | 1 | March 1, 2023 | 0 | 0 | 0 | api.fda.gov |
| Finemedix | Daegu Gwangyeogsi, South Korea | Manufacturer | 1 | April 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| Ga Health Company Limited | Hong Kong, Hong Kong | Complaint file establishment, Exporter to the US, Specification developer | 1 | May 11, 2023 | 0 | 0 | 0 | api.fda.gov |
| Gyrus Acmi, Inc. | Westborough, MA, United States | Specification developer | 1 | March 18, 2020 | 0 | 0 | 0 | api.fda.gov |
| Intuit Medical Products, LLC | Lawrenceville, GA, United States | Specification developer | 1 | July 27, 2016 | 0 | 0 | 0 | api.fda.gov |
| Leadoptik Inc. | San Jose, CA, United States | Manufacturer | 1 | December 19, 2025 | 0 | 0 | 0 | api.fda.gov |
| Micro-Tech (Nanjing) Co., Ltd. | Nanjing Jiangsu, China | Manufacturer | 1 | July 20, 2022 | 0 | 0 | 0 | api.fda.gov |
| Micro-Tech (Nanjing) Co., Ltd. | NAN JING Jiangsu, China | Manufacturer | 1 | July 20, 2022 | 0 | 0 | 0 | api.fda.gov |
| Olympus Vietnam Co. Ltd. | Dong Nai City, Vietnam | Manufacturer | 1 | July 29, 2025 | 0 | 0 | 0 | api.fda.gov |
| Praxis Medical LLC | Tampa, FL, United States | Specification developer | 1 | September 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| Serpex Medical, Inc. | Santa Clara, CA, United States | Complaint file establishment, Specification developer | 1 | October 8, 2025 | 0 | 0 | 0 | api.fda.gov |
| Biomerics Alajuela | Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Centerpoint Systems LLC | West Valley City, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Consolidated Medical Equipment Company | Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Bloomington, IN, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qsa Surgical (pvt) Ltd. | SIALKOT Punjab, Pakistan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quadrant Technologies, LLC | Grayslake, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richard Wolf GMBH | KNITTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Resolution Medical | Minneapolis, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smartdata Suzhou Co., Ltd | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.