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OXYGEN SENSORS - T1

by Teledyne Analytical Instruments

510(k) K001095

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 NumberK001095 Date30 Jun 2000ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-3001-2011 FDA Unclassified (pre-2012) initiated 29 Nov 2010 on shared 510(k) K001095

    The recall was initiated because during a test on a batch of sensors on the company shipping dock, Teledyne Instruments discovered electrolyte loss from the sealing cylinder on a few sensors. This test was done pursuant to a complaint from one customer of label discoloration caused because of the electrolyte loss. The risk of a leak form the oxygen sensor while in use is the disruption of therape

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
CCL
Models / Variants
T1
Device Class
Class II
Regulation
21 CFR Part 868.1720
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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