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Calcium Electrode 7207

by Medica Corp.

Calcium Electrode 7207 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 00386100002602), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K021515; other models may be affected

Documents

510(k) K021515

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00386100002602 UDI-DI Date5 Dec 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK021515 Date16 Jul 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K021515 decided 16 Jul 2002 Active
  • FDA GUDID UDI-DI 00386100002602 listed 5 Dec 2018 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1370-2026 FDA Class II initiated 31 Dec 2025 on shared 510(k) K021515

    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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

3 dated events

  1. Cleared FDA 510(k) K021515
  2. Listed FDA GUDID 00386100002602
  3. Recall initiated FDA recalls Z-1370-2026

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Calcium Electrode
Generic name
Calcium (Ca2+) electrode IVD
Model / Ref / Catalog
7207
Primary DI / UDI-DI
00386100002602
510(k) Number
FDA product code
JFP
GMDN term
Calcium (Ca2+) electrode IVD
Device class
Class II
Regulation number
862.1145
GUDID distribution status
In Commercial Distribution

Related devices

Category: Calcium (Ca2+) electrode IVD

Cleared under the same submission (K021515)

and 8 more cleared under K021515

Similar devices

Other devices filed under FDA product code JFP (Electrode, Ion Specific, Calcium).

Other devices from Medica Corp.

See all devices from Medica Corp. →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)