# K971968: Safe Connect Surgical Cable (S-101-97/S-201-97/FL-601-97)

- Pathway: 510(k) (Traditional)
- Applicant: Remington Medical, Inc.
- Decided: Jul 23, 1997 after 56 days
- Product code: DSA (Cable, Transducer And Electrode, Patient, (Including Connector))
- Device class: 2
- Regulation: 21 CFR 870.2900
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K093858: Psa Cable, Models 4160 and 4161 and Psa Cable Adapter, Model 4053A (2010), 1 descendant of its own
- K152947: Disposable Temporary Pacing Cable (2016), 0 descendants of its own
- K101982: Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter EX3180 (2010), 0 descendants of its own

## Recalls of this device
- Mar 5, 2014 · Class II · Z-1441-2014: Remington Medical discovered an error on the FL-601-97 IFU; part number IFU-RM-0154. Specifically, the polarity for the black chuck in the picture is wrong. It shows (+), but should show (-).
- May 19, 2010 · Not classified · Z-2223-2010: The Safe Connect component may separate from the cable, causing the cable to become unplugged from the EPG.

## Indications for use
The Remington Medical Disposable Surgical Extension Cable is an electrical extension cable used to transmit signal from, or power or excitation signal to patient-connected electrodes. The cable is bipolar, providing alligator clips at the end of the cable that will be attached to the patient's lead, and a safety plug at the other end that allows electrical connection to the external pacemaker or testing device (i.e. analyzer). The alligator clips are color coded and imprinted with the polarity: The red clips are positive (+) and the black clips are negative (-). The cable is designed to carry a maximum electrical load of 300 volts, and will be compatible with most external pacemakers, pace analyzers, and patient pacing leads currently on the market. The cable is a sterile, disposable device.

Source page: https://510kreport.com/device/K971968
Methodology: https://510kreport.com/methodology