SourceMark M1206
SourceMark M1206 is a Class II device made by Sourcemark, LLC., cleared under FDA 510(k) K132243 on 20 Dec 2013 and listed in FDA GUDID since 9 Jul 2020 (UDI-DI 00813799005114), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00813799005114 | Date9 Jul 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK132243 | Date20 Dec 2013 | StatusActive |
Official records
- AccessGUDID record 00813799005114
- FDA 510(k) database K132243
Across registries
- FDA 510(k) K132243 decided 20 Dec 2013 Active
- FDA GUDID UDI-DI 00813799005114 listed 9 Jul 2020 Listed
Recalls
-
- Ongoing Z-1788-2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.
Timeline
- Cleared FDA 510(k) K132243
- Listed FDA GUDID 00813799005114
- Recall initiated FDA recalls Z-1788-2022
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SourceMark
- Generic name
- General-purpose patient temperature probe, single-use
- Model / reference
- M1206
- Primary DI / UDI-DI
- 00813799005114
- 510(k) Number
- FDA product code
- MPN
- GMDN term
- General-purpose patient temperature probe, single-use
- Device class
- Class II
- Regulation number
- 878.4010
- GUDID distribution status
- In Commercial Distribution