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Med-Dyne R24DS

by Med-Dyne

Med-Dyne R24DS is a Class II device made by Med-Dyne, cleared under FDA 510(k) K080112 on 20 Jun 2008 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00817497021445), active as of 22 Oct 2026. One FDA recall is linked to it.

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

This device is named in the recall

Documents

510(k) K080112

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817497021445 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK080112 Date20 Jun 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K080112 decided 20 Jun 2008 Active
  • FDA GUDID UDI-DI 00817497021445 listed 24 Sep 2016 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2553-2019 FDA Class II initiated 1 Aug 2019

    The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm.

Timeline

3 dated events

  1. Cleared FDA 510(k) K080112
  2. Listed FDA GUDID 00817497021445
  3. Recall initiated FDA recalls Z-2553-2019

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Med-Dyne
Generic name
Electrocardiographic electrode, single-use
Model / reference
R24DS
Primary DI / UDI-DI
00817497021445
510(k) Number
FDA product code
DSA
GMDN term
Electrocardiographic electrode, single-use
Device class
Class II
Regulation number
870.2900
GUDID distribution status
In Commercial Distribution
Size
Length — 24 Inch

Related devices

Category: Electrocardiographic electrode, single-use

Cleared under the same submission (K080112)

and 8 more cleared under K080112

Similar devices in this category

Other devices filed under Electrocardiographic electrode, single-use.

Other devices from Med-Dyne

See all devices from Med-Dyne →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)