# K010728: Harmone-Schwarzer Eeg System

- Pathway: 510(k) (Abbreviated)
- Applicant: Stellate Systems
- Decided: May 21, 2001 after 70 days
- Product code: OLV (Standard Polysomnograph With Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K080217: Component Neuromonitoring System (2008), 14 descendants of its own
- K092573: Nihon Kohden QP-160AK Eeg Trend Program (2010), 7 descendants of its own
- K120485: Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT P (2012), 5 descendants of its own
- K173366: NicoletOne (2018), 3 descendants of its own
- K213299: Wireless EEG System (2022), 2 descendants of its own

## Recalls of this device
- Apr 6, 2009 · Class II · Z-1080-2013: The firm is initiating this recall because the implied or stated indications in their labeling associated with Harmonie software have not yet been cleared by the FDA for sale in the USA.

Source page: https://510kreport.com/device/K010728
Methodology: https://510kreport.com/methodology