RAPIDPOINT® 340 Sampler Module 10375808
by Siemens Healthcare Diagnostics Inc.
RAPIDPOINT® 340 Sampler Module 10375808 is a Class II device made by Siemens Healthcare Diagnostics Inc., cleared under FDA 510(k) K021515 on 16 Jul 2002 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00630414568584), active as of 23 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 | Number00630414568584 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK021515 | Date16 Jul 2002 | StatusActive |
Official records
- AccessGUDID record 00630414568584
- FDA 510(k) database K021515
Across registries
- FDA 510(k) K021515 decided 16 Jul 2002 Active
- FDA GUDID UDI-DI 00630414568584 listed 24 Sep 2016 Listed
Recalls
-
- Ongoing Z-1370-2026
A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.
Timeline
- Cleared FDA 510(k) K021515
- Listed FDA GUDID 00630414568584
- Recall initiated FDA recalls Z-1370-2026
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- RAPIDPOINT® 340 Sampler Module
- Generic name
- Blood gas/haemoximetry analyser IVD, point-of-care
- Model / Ref / Catalog
- 10375808
- Primary DI / UDI-DI
- 00630414568584
- 510(k) Number
- FDA product code
- JFP, CEM, JGS, CHL, GKF
- GMDN term
- Blood gas/haemoximetry analyser IVD, point-of-care
- Device class
- Class II
- Regulation number
- 862.1145, 862.1600, 862.1665, 862.1120, 864.5600
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Blood gas/haemoximetry analyser IVD, point-of-care.