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Nebulizer Adapter

by Respiratory Care, Inc.

510(k) K772348

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 NumberK772348 Date3 Jan 1978ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0211-2008 FDA Unclassified (pre-2012) initiated 22 Aug 2007

    Decreased in flow output; through the nebulizer -(when used at higher oxygen concentration settings, this decrease in flow, may lower the oxygen concentration inspired by the patient)

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  • Withdrawn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
CAF
Device Class
Class II
Regulation
21 CFR Part 868.5630
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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