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Ysi 400 Series Atuoclavable Reusable Temperature Probe

by Yellow Springs Instrument Co., Inc.

510(k) K962070

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

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 NumberK962070 Date19 Jul 1996ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-0926-2022 FDA Class II initiated 7 Feb 2022 on shared 510(k) K962070

    Update to instructions for use regarding the cleaning and disinfection process for the reusable probes.

    • Ongoing Z-0395-2018 FDA Class II initiated 13 Mar 2017

    The reusable temperature probes are provided with instructions for sterilization that have not been proven through a validation study.

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  • Withdrawn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
FLL
Device Class
Class II
Regulation
21 CFR Part 880.2910
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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