# K900098: Monopolar Needle Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Oculinum, Inc.
- Decided: Feb 9, 1990 after 32 days
- Product code: HLW (Preamplifier, Battery-Powered, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.1640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
56 later devices descend from it; 1 cites it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K990015: Electrode Needles (1999), 55 descendants of its own
- K022914: Rhythmlink International Subdermal Needle Electrodes (2002), 50 descendants of its own
- K112718: Nuvasive NVM5 System (2012), 35 descendants of its own
- K123307: Nuvasive NVM5 System (2013), 33 descendants of its own
- K132694: Nuvasive NVM5 System (2014), 24 descendants of its own

Source page: https://510kreport.com/device/K900098
Methodology: https://510kreport.com/methodology