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Neonatal ConchaSmart Breathing Circuits

by Teleflexmedical, Inc.

510(k) K173280

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK173280 Date2 Aug 2018ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1912-2019 FDA Class I initiated 10 May 2019

    Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.

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  • Withdrawn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
BZE
Device Class
Class II
Regulation
21 CFR Part 868.5270
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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