Patient Cable

510(k) K080112

Patient Cable is a Class II device made by Med-Dyne, cleared under FDA 510(k) K080112 on 20 Jun 2008, active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States

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 record

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK080112	Date20 Jun 2008Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K080112

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

2 dated events

20 Jun 2008 Cleared FDA 510(k) K080112
1 Aug 2019 Recall initiated FDA recalls Z-2553-2019

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K080112
FDA product code: DSA

Device class: Class II
Regulation: 21 CFR Part 870.2900
Advisory committee: Cardiovascular
FDA decision: SESE Substantially Equivalent

Devices cleared under K080112

28 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K080112
		UDI-DI	Size and differences
Med-Dyne G24AL MED-DYNE	G24AL	00817497020530	Length 24 in Single use: yes	On the market
Med-Dyne G24AR MED-DYNE	G24AR	00817497020547	Length 24 in Single use: yes	On the market
Med-Dyne G24AR-30 MED-DYNE	G24AR-30	00817497020554	Length 24 in Single use: yes	On the market
Med-Dyne G24AS MED-DYNE	G24AS	00817497020561	Length 24 in Single use: yes	On the market
Med-Dyne G24BS MED-DYNE	G24BS	00817497020578	Length 24 in Single use: yes	On the market
Med-Dyne G4830-30 MED-DYNE	G4830-30	00817497020585	Single use: yes	On the market
Med-Dyne G48AS MED-DYNE	G48AS	00817497020592	Length 48 in Single use: yes	On the market
Med-Dyne G536L MED-DYNE	G536L	00817497020608	Length 36 in Single use: yes	On the market
Med-Dyne G536S MED-DYNE	G536S	00817497020615	Length 36 in Single use: yes	On the market
Med-Dyne G60AS MED-DYNE	G60AS	00817497020622	Length 60 in Single use: yes	On the market
Med-Dyne GE84 MED-DYNE	GE84	00817497022992	Length 24 in Single use: yes	On the market
Med-Dyne GE84-40 MED-DYNE	GE84-40	00817497020844	Length 24 in Single use: yes	On the market
Med-Dyne GE84-60 MED-DYNE	GE84-60	00817497020851	Length 24 in Single use: yes	On the market
Med-Dyne GL4024-40 MED-DYNE	GL4024-40	00817497020998	Length 24 in Single use: yes	On the market
Med-Dyne GL7024-30 MED-DYNE	GL7024-30	00817497021001	Length 24 in Single use: yes	On the market
Med-Dyne R24AD MED-DYNE	R24AD	00817497021353	Length 24 in Single use: yes	On the market
Med-Dyne R24AL MED-DYNE	R24AL	00817497021360	Length 24 in Single use: yes	On the market
Med-Dyne R24AR MED-DYNE	R24AR	00817497021377	Length 24 in Single use: yes	On the market
Med-Dyne R24AS MED-DYNE	R24AS	00817497021384	Length 24 in Single use: yes	On the market
Med-Dyne R24AS2 MED-DYNE	R24AS2	00817497021391	Length 24 in Single use: yes	On the market
Med-Dyne R24CD MED-DYNE	R24CD	00817497021407	Length 24 in Single use: yes	On the market
Med-Dyne R24CL MED-DYNE	R24CL	00817497021414	Length 24 in Single use: yes	On the market
Med-Dyne R24CR MED-DYNE	R24CR	00817497021421	Lumen/Inner Diameter 24 in Single use: yes	On the market
Med-Dyne R24CS MED-DYNE	R24CS	00817497021438	Length 24 in Single use: yes	On the market
Med-Dyne R24DS MED-DYNE	R24DS	00817497021445	Length 24 in Single use: yes	On the market
Med-Dyne SCL8000 MED-DYNE	SCL8000 / SCL8000	00868795000205	Circumference 0.80 in; Length 24 in Single use: no	On the market
Med-Dyne SCL9000 MED-DYNE	SCL9000 / SCL9000	00868795000212	Single use: no	On the market
Med-Dyne SCL9000L MED-DYNE	SCL9000L	00817497021919	Length 20 Feet Single use: yes	On the market

Similar devices

Other devices filed under FDA product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)).

Other devices from Med-Dyne

Med-Dyne SBK24

Class II
Med-Dyne G536S Open recall

Class II
Med-Dyne 381-004

Class II
Med-Dyne SYL24

Class II

See all devices from Med-Dyne →

Regulatory status

Recalls

Timeline

Coverage

Specification

Devices cleared under K080112

Similar devices

Other devices from Med-Dyne

Med-Dyne SBK24

Med-Dyne G536S Open recall

Med-Dyne 381-004

Med-Dyne SYL24