# K242447: Falcon HST

- Pathway: 510(k) (Traditional)
- Applicant: Compumedics Limited
- Decided: Feb 20, 2025 after 188 days
- Product code: OLV (Standard Polysomnograph With Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K913396 (1992). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172986: Zmachine Synergy, Consolidated Research of Richmond, Inc. Dba General Sleep CO (2017) Summary page 5.
- K101830: Zmachine, Model DT-100, Consolidated Research of Richmond, Inc. (2011) Summary page 5.

## Indications for use
The Falcon HST is an EEG and respiratory signal recorder. The device is intended for use by adult patients in the home or clinical environment, under the direction of a qualified healthcare practitioner, to aid in the diagnosis of sleep disorders.

Source page: https://510kreport.com/device/K242447
Methodology: https://510kreport.com/methodology