# K990199: Smartrecorder, Model 2500

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Apr 19, 1999 after 88 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: 2 generations back to K971867 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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.
- K962603: Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables, Masimo Corp. (1997) Summary page 1.
- K983572: Simon Multichannel Recording System, Model 5500, Healthdyne Technologies, Inc. (1999). Cleared while this submission was under review Summary page 1.

## Indications for use
The Respironics SmartRecorder is a multichannel recording system designed to record and store physiologic signals acquired from adult and infant patients during sleep. SmartRecorder is designed for use in the home or hospital. Physiological signals are acquired via transducers attached to the patient and directly connected to the recorder and/or monitoring or therapeutic device connected to the recorder. Use of the associated Synergy S (host) software facilitates retrieval of data recorded by SmartRecorder via direct PC connection; remotely via internal modem; or by transferring data directly from the removable PCMCIA memory card to a PC. Once downloaded, the recorded data can be analyzed for physiological events. Synergy S allows the clinician can display, review, edit and print analyzed data as well as configure / customize all reports to best meet individual needs.

Source page: https://510kreport.com/device/K990199
Methodology: https://510kreport.com/methodology