Data / Medical devices / Taiwan / Vitaltec Corporation
Vitaltec Corporation: FDA-registered device maker in Taichung, Taiwan, 2 510(k) clearances
Vitaltec Corporation is registered with the FDA (registration 3040279832) in Taichung, Taiwan. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated September 11, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3040279832
- Address
- No. 12, Lane 4-30, Chyuan-Zhou Rd., Hou-Li Dist., Taichung, Taiwan, 42142
- Owner or operator
- Vitaltec Corporation (10091432)
- Roles
- Manufacturer
- First device listed
- July 22, 2025
- Registered through
- 2027
- Brand names listed
- Rota-Trach Disposable Standard Tracheostomy Tube, Venti-Trach Tracheostomy Tube (570 Series; 571 Series; 580 Series; 581 Series)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Tube, Tracheostomy (W/Wo Connector) | BTO | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 11, 2026 | K253063 | Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) | BTO | Substantially Equivalent | Vitaltec Corporation | accessdata.fda.gov |
| June 10, 2025 | K242921 | 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm | BTO | Substantially Equivalent | Vitaltec Corporation | accessdata.fda.gov |
Compare with other makers
Updated September 11, 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.