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ENDURAVENT-5 Ventilator

by Providence Global Medical, Inc.

510(k) K092263

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK092263 Date21 Jan 2010ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CBK
Device Class
Class II
Regulation
21 CFR Part 868.5895
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The EnduraVent-5 Ventilator is a continuous-use, facility-based mechanical ventilator designed for adult and pediatric patients weighing over 9 kg. It delivers controlled or assisted ventilation to support respiratory function during clinical procedures, with applications primarily in anesthesia and critical care settings.

This device is intended for in-hospital transport and is supplied as a reusable medical instrument. It is classified under FDA regulation 868.5895 and has received FDA 510(k) clearance (K092263) as substantially equivalent to a predicate device. The ventilator operates within Class II regulatory controls and is intended for use in controlled environments such as operating rooms, emergency departments, or intensive care units.

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