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Phoneris Inner Cannulae With Phoneris Aero-Flex Ventilator Circuit Connector

by Lazarus Medical, LLC

510(k) K073702

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 NumberK073702 Date26 Jun 2008ClearedStatusActive

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  • Withdrawn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
BTO
Device Class
Class II
Regulation
21 CFR Part 868.5800
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

The Phoneris Inner Cannulae With Phoneris Aero-Flex Ventilator Circuit Connector is a device for airway maintenance of tracheostomised patients, serving as an interlocking, detachable coupling between the ventilator circuit and tracheostomy tube. It is an accessory to a tracheostomy tube.

The device is a single-use, disposable product, supplied for use in anesthesiology. It has been found substantially equivalent to a predicate device and has an FDA 510K authorization. The device is used for airway maintenance and is designed for use with a tracheostomy tube and ventilator circuit.

Other devices from Lazarus Medical, Inc.