Skip to content

Temp Probe

by LivaNova USA, Inc. 2 variants

Temp Probe is a Class II device made by LivaNova USA, Inc., cleared under FDA 510(k) K962070 on 19 Jul 1996 and listed in FDA GUDID since 1 Aug 2016 (UDI-DI 00803622133145), active as of 19 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

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

510(k) K962070

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 19 Oct 2026.

Regulatory status

as of registry sync 19 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00803622133145 UDI-DI Date1 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK962070 Date19 Jul 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K962070 decided 19 Jul 1996 Active
  • FDA GUDID UDI-DI 00803622133145 listed 1 Aug 2016 Listed

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.

Timeline

4 dated events

  1. Cleared FDA 510(k) K962070
  2. Listed FDA GUDID 00803622133145
  3. Recall initiated FDA recalls Z-0395-2018
  4. Recall initiated FDA recalls Z-0926-2022

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
General-purpose patient temperature probe, reusable
Model / reference
Temp Probe
Primary DI / UDI-DI
00803622133145
510(k) Number
FDA product code
FLL
GMDN term
General-purpose patient temperature probe, reusable
Device class
Class II
Regulation number
880.2910
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: General-purpose patient temperature probe, reusable

Cleared under the same submission (K962070)

Similar devices in this category

Other devices filed under General-purpose patient temperature probe, reusable.

Other devices from LivaNova USA, Inc.

  • Perfusion Pack

    Class II

  • Perfusion Pack

    Class II

  • Perfusion Pack

    Class II

  • Perfusion Pack

    Class II

See all devices from LivaNova USA, Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)