# K211941: 9Line

- Pathway: 510(k) (Traditional)
- Applicant: Energetic Designs, Inc.
- Decided: Jan 27, 2022 after 218 days
- Product code: DSA (Cable, Transducer And Electrode, Patient, (Including Connector))
- Device class: 2
- Regulation: 21 CFR 870.2900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K992524 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170536: ECG Disposable Lead Wire, APK Technology Co., Ltd. (2017) Summary page 4.

## Indications for use
9Line patient leadwires are intended to be used to connect electrodes placed at appropriate sites on the patient to an ECG or EKG monitoring device for general monitoring and/or diagnostic evaluation by a healthcare professional. The device is intended for single-patient use.

Source page: https://510kreport.com/device/K211941
Methodology: https://510kreport.com/methodology