SourceMark M0535C
by Sourcemark, LLC. 2 variants
SourceMark M0535C is a Class II device made by Sourcemark, LLC., cleared under FDA 510(k) K042683 on 18 Feb 2005 and listed in FDA GUDID since 8 Jul 2020 (UDI-DI 00813799000874), 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 | Number00813799000874 | Date8 Jul 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK042683 | Date18 Feb 2005 | StatusActive |
Official records
- AccessGUDID record 00813799000874
- FDA 510(k) database K042683
Across registries
- FDA 510(k) K042683 decided 18 Feb 2005 Active
- FDA GUDID UDI-DI 00813799000874 listed 8 Jul 2020 Listed
Recalls
-
- Ongoing Z-3172-2026
The 6Fr suction catheter could not pass through the samples smoothly.
Timeline
- Cleared FDA 510(k) K042683
- Listed FDA GUDID 00813799000874
- Recall initiated FDA recalls Z-3172-2026
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SourceMark
- Generic name
- Basic endotracheal tube, single-use
- Model / reference
- M0535C
- Primary DI / UDI-DI
- 00813799000874
- 510(k) Number
- FDA product code
- BTR
- GMDN term
- Basic endotracheal tube, single-use
- Device class
- Class II
- Regulation number
- 868.5730
- GUDID distribution status
- In Commercial Distribution
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