Breathe Technologies Ventilator BT-V2S

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Breathe Technologies Ventilator and Accessories (Bt-V2S)

510(k) Number

K102525 ↗

FDA Product Code

ONZ

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Breathe Technologies LIFE2000 Ventilation System

  Class II

  FDA 510(k) K141943 Active Cleared 12 Jun 2015

• Breathe Technologies Ventilator and Accessories Bt-V2S

  Class II

  FDA 510(k) K100528 Active Cleared 23 Apr 2010

• Breathe Niov Ventilation System

  Class II

  FDA 510(k) K131562 Active Cleared 6 Mar 2014

• Breathe Technologies Life2000™ Ventilation System Open recall

  Class II

  FDA 510(k) K170037 Active Cleared 11 Aug 2017

• Breathe Technologies Ventilator and Accessories

  Class II

  FDA 510(k) K082982 Active Cleared 20 Jul 2009

• Breathe Technologies Ventilator and Accessories (Bt-V2S)

  Class II

  FDA 510(k) K103345 Active Cleared 11 Feb 2011

See all devices from Breathe Technologies, Inc. →

• What types of patients is the BT-V2S ventilator designed to support, and what does that mean for clinical use?

  The BT-V2S is designed to assist adult patients with respiratory insufficiency who can sustain a minimum tidal volume of 3.5 cc/kg of predicted body weight. This means it is intended for patients who can breathe spontaneously but require mechanical support, including those with or without a tracheostomy. Clinically, this makes it suitable for settings where patients need ventilatory assistance while maintaining some level of spontaneous breathing effort, such as ICU recovery or post-operative care.

• Is the BT-V2S ventilator a single-use or reusable device, and what does that imply for maintenance and cost?

  The BT-V2S is explicitly described as a reusable medical device. This implies that it is designed for repeated use in clinical settings, requiring proper cleaning, disinfection, and maintenance protocols to ensure safety and functionality. Reusability can impact cost structures, as facilities will need to account for maintenance, servicing, and potential repairs over time rather than disposing of the device after each use.

• How is the BT-V2S ventilator supplied, and what accessories are included with it?

  The BT-V2S is supplied *with accessories*, though the specific components are not detailed in the provided data. This suggests it comes as a complete system ready for clinical use, including essential tubing, connectors, or other necessary attachments. Buyers should confirm the full accessory kit with the manufacturer to ensure compatibility with their patient population and workflow.

• What regulatory pathway was followed for the BT-V2S, and how does that affect its use in hospitals?

  The BT-V2S was cleared via the FDA’s 510(k) process (K102525) under the Traditional pathway, with a determination of *Substantially Equivalent* to a predicate device. This means it was reviewed by the FDA’s Anesthesiology Advisory Committee (AN) and classified as a Class II device under regulation 868.5895. Clinically, this clearance implies the device meets FDA standards for safety and effectiveness as a mechanical ventilator, allowing hospitals to use it with confidence in regulated settings.