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Salter Labs Oral/Nasal Thermal Airflow Sensor

by Salter Labs, Division of Regulatory Affairs

510(k) K080922

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 NumberK080922 Date25 Jul 2008ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1028-2011 FDA Unclassified (pre-2012) initiated 21 Dec 2010

    The incorrect length and connector were utilized in lot 110810 of the ThermiSense Alice 5, making the product unusable as it will not interface with the sleep labs equipment.

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  • Withdrawn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
BZQ
Device Class
Class II
Regulation
21 CFR Part 868.2375
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent