# K011564: Neolead

- Pathway: 510(k) (Traditional)
- Applicant: Neotech Products, Inc.
- Decided: Jan 3, 2002 after 227 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
No predicates in its family tree.
30 later devices descend from it; 4 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Kittycat-Kendall-LTP: named in the summary without a submission number
- (no number) Neotrode-ConMe Corp: named in the summary without a submission number
- (no number) Klear-Trace-CAS Medical Systems, Inc: named in the summary without a submission number
- (no number) SilveReez-Clinimark: named in the summary without a submission number
- (no number) H/P —HewlettPackard: named in the summary without a submission number
- (no number) NeoBar: named in the summary without a submission number
- (no number) NeoSmile: named in the summary without a submission number
- (no number) NeoBridge: named in the summary without a submission number
- (no number) NeoHold: named in the summary without a submission number
- (no number) NeoShades: named in the summary without a submission number
- (no number) NeoBond: named in the summary without a submission number

## Most influential descendants
- K050443: Accu-Lead (2005), 27 descendants of its own
- 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

## Indications for use
The NeoLead Hydrocolloid/ Hydrogel electrode is intended to be used for resting ECG monitoring on neonatal and pediatric patients in a hospital setting.

Source page: https://510kreport.com/device/K011564
Methodology: https://510kreport.com/methodology