# Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) (K253063): 510(k) cleared for Vitaltec Corporation

**Predicate Speed & CAPA Advisory Opportunity Score:** 60/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K253063 |
| Device | Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) |
| Applicant | Vitaltec Corporation |
| Specialty / panel | Anesthesiology |
| Product code | BTO |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2025-09-22 |
| Decision date | 2026-09-11 |
| Review time (days) | 354 |
| Third-party review | No |
| Applicant location | Taichung City, TW |

## Why this score
- A long 354-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Special 510(k): a modification of an existing device.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253063). Last refreshed: 2026-11-03T18:05:14.713Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.