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 30 May 2018 (UDI-DI 00803622140228), active as of 19 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
2 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00803622140228 | Date30 May 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK962070 | Date19 Jul 1996 | StatusActive |
Official records
- AccessGUDID record 00803622140228
- FDA 510(k) database K962070
Across registries
- FDA 510(k) K962070 decided 19 Jul 1996 Active
- FDA GUDID UDI-DI 00803622140228 listed 30 May 2018 Listed
Recalls
-
- Ongoing Z-0926-2022
Update to instructions for use regarding the cleaning and disinfection process for the reusable probes.
-
- Ongoing Z-0395-2018
The reusable temperature probes are provided with instructions for sterilization that have not been proven through a validation study.
Timeline
- Cleared FDA 510(k) K962070
- Recall initiated FDA recalls Z-0395-2018
- Listed FDA GUDID 00803622140228
- Recall initiated FDA recalls Z-0926-2022
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- General-purpose patient temperature probe, reusable
- Model / reference
- Temp Probe
- Primary DI / UDI-DI
- 00803622140228
- 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
Similar devices in this category
Other devices filed under General-purpose patient temperature probe, reusable.
- Reusable skin temperature probe 011-01405 by Sensatronic GmbH
- ST3304 07-10-00 by Shenzhen SINO-K Medical Technology Co., Ltd
- CO-SET INJECTATE ICE BUCKET 93520 by Edwards Lifesciences LLC
- Temperature probe TS-CM03-PS10 by Orantech Inc.
- Temp Probe Reusable Adult 3m 5204644 by Draeger Medical Systems, Inc.
- ST2304 07-10-00 by Shenzhen SINO-K Medical Technology Co., Ltd
- Temperature Sensors - by Beijing Rongrui-Century Science & Technology Co., Ltd.
- Temperature probe TS-BE03-AS20 by Orantech Inc.
- RespArray Temperature probe 02.57.225244 by Edan Instruments, Inc.
- Temp Probe Adult 1.5m Reusable 4329889 by Draeger Medical Systems, Inc.