Potassium Electrode 7206
by Medica Corp.
Potassium Electrode 7206 is a Class II device made by Medica Corp., cleared under FDA 510(k) K021515 on 16 Jul 2002 and listed in FDA GUDID since 5 Dec 2018 (UDI-DI 00386100002466), 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 | Number00386100002466 | Date5 Dec 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK021515 | Date16 Jul 2002 | StatusActive |
Official records
- AccessGUDID record 00386100002466
- FDA 510(k) database K021515
Across registries
- FDA 510(k) K021515 decided 16 Jul 2002 Active
- FDA GUDID UDI-DI 00386100002466 listed 5 Dec 2018 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 00386100002466
- Recall initiated FDA recalls Z-1370-2026
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Potassium Electrode
- Generic name
- Potassium (K+) electrode IVD
- Model / Ref / Catalog
- 7206
- Primary DI / UDI-DI
- 00386100002466
- 510(k) Number
- FDA product code
- CEM
- GMDN term
- Potassium (K+) electrode IVD
- Device class
- Class II
- Regulation number
- 862.1600
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Potassium (K+) electrode IVD.