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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K253063

510(k) cleared

Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series)

Vitaltec Corporation · Sep 11, 2026 · K253063

FDA cleared the Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) from Vitaltec Corporation on Sep 11, 2026 under K253063, a special 510(k). The device falls under product code BTO, Tube, Tracheostomy (W/Wo Connector), regulated at 21 CFR 868.5800 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Sep 22, 2025. The decision came 354 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Vitaltec Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253063?

K253063 is the FDA 510(k) for Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series), submitted by Vitaltec Corporation. FDA's decision date was Sep 11, 2026, under product code BTO (Tube, Tracheostomy (W/Wo Connector)).

Who makes the Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series)?

Vitaltec Corporation, based in Taichung City, is the applicant of record for K253063.

How long did the K253063 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on Sep 11, 2026, 354 days later.

← All decisions in September 2026