Clearance Summary
Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) received FDA 510(k) clearance under submission number K253063, sponsored by Vitaltec Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2026-09-11.
- Submission: K253063
- Applicant / Sponsor: Vitaltec Corporation
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5800
- Decision date: 2026-09-11
Classification & Regulation
This clearance is catalogued under FDA product code BTO and 21 CFR 868.5800, within the Anesthesiology review panel as a Class II device.