# K050443: Accu-Lead

- Pathway: 510(k) (Traditional)
- Applicant: Kentec Medical, Inc.
- Decided: Sep 2, 2005 after 192 days
- Product code: DRX (Electrode, Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011564 (2002). 1 ancestor in all.
27 later devices descend from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011564: Neolead, Neotech Products, Inc. (2002) Summary page 1.

## Most influential descendants
- K092744: Neonatal Ecg Electrode, M203KEN (2009), 26 descendants of its own
- K132694: Nuvasive NVM5 System (2014), 24 descendants of its own
- K141968: Nuvasive NVM5 System (2014), 23 descendants of its own
- K143641: NuVasive NVM5 System (2015), 22 descendants of its own
- K152942: NuVasiveNVM5 System (2016), 13 descendants of its own

## Indications for use
Single Use Only - Disposable The NEONATAL PEDIATRIC ECG ELECRODE is intended for use whenever cardiac monitoring of neonatal or pediatric patients is deemed or desirable by trained medical or emergency personnel. This electrode is for use on the surface of the body.

Source page: https://510kreport.com/device/K050443
Methodology: https://510kreport.com/methodology