# K083674: PK-141 Patient Cable

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Apr 1, 2009 after 111 days
- Product code: DTC (Analyzer, Pacemaker Generator Function)
- Device class: 2
- Regulation: 21 CFR 870.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K883930 (1988). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022360: Era 3000; PA-2 IS-1 Adapter; EK-4-N Pacemaker Test Cable; Era 3000 Charger; Era 3000 Battery (Type 2); NK-11 Power Supp., Biotronik, Inc. (2003) Summary page 1.

## Most influential descendants
- K170815: PSA Cable (2017), 0 descendants of its own

## Indications for use
The PK-141 patient cable is an accessory indicated for use with external equipment from BIOTRONIK and is used for the transmission of sensing signals and pacing pulses for diagnostics and therapy in the context of intracardiac examinations including the following activities: Temporary External Pacing Provides temporary stimulation during implantable pacemaker procedures or physician evaluations. Lead Threshold Determination Determines in situ lead characteristics of impedance, capture threshold, P/R wave amplitude and P/R wave slew rate. Determines the in vivo retrograde conduction time. Pacemaker Function Test Tests and analyzes the.in vitro operation of external or implantable pulse generators. Determines the following parameters: pulse amplitude arid width, A/V delay, and rate/interval.

Source page: https://510kreport.com/device/K083674
Methodology: https://510kreport.com/methodology