# K983572: Simon Multichannel Recording System, Model 5500

- Pathway: 510(k) (Traditional)
- Applicant: Healthdyne Technologies, Inc.
- Decided: Mar 19, 1999 after 157 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- 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 K971867 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971867: Alice 4R System, Healthdyne Technologies, Inc. (1997) Summary page 1.

## Most influential descendants
- K990199: Smartrecorder, Model 2500 (1999), 0 descendants of its own

## Indications for use
Simon™ is a multichannel recording system designed to record and store physiological signals acquired from adult and pediatric patients during sleep. The portable design of the device facilitates its use in any clinical setting or in the home environment. Physiological signals are acquired via transducers attached to the patient and directly connected to the recorder. Additionally, a modem may be used to connect to the Host PC during acquisition, to interface with a Respironics CPAP or BiPAP device for titration or to download the data post acquisition. Once downloaded, the recorded data can be scored for physiological events using the associated Simon™ HOST Software. The clinician can review, validate, edit and print scored data. The software allows the user to configure / customize all reports to best meet individual needs.

Source page: https://510kreport.com/device/K983572
Methodology: https://510kreport.com/methodology