510(k) · Cleared
ClearedSimon Multichannel Recording System, Model 5500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthdyne Technologies, Inc. · MNR Ventilatory Effort Recorder
Cleared on Mar 19, 1999 as substantially equivalent to K971867 (Healthdyne Technologies, Inc., 1997) after a 157-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.
- Decided
- Mar 19, 1999
- Review
- 157 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971867 (1997). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K990199Smartrecorder, Model 2500Respironics, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971867 | Alice 4R System | Healthdyne Technologies, Inc. | 1997 | — |
| 0 (this device) | K983572 | Simon Multichannel Recording System, Model 5500 | Healthdyne Technologies, Inc. | 1999 | — |
| +1 | K990199 | Smartrecorder, Model 2500 | Respironics, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MNR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MNR device
- #1 K244027 Sansa Hsatscore 18.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K971867 | Alice 4R SystemSummary page 1…ader Simon™ Multichannel Recording System 5500 Programmable Diagnostic Computer, 21 CFR 870.1425 DQK Healthdyne Technologies’ Alice 4 System. Originally cleared under K971867 (8/13/97). Simon™ is a multichannel recording system, which may be used for adult or pediatric patients in a variety of settings… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990199 | Smartrecorder, Model 2500 | 1999 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNR
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MNR
165in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNR
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNR
43in 2025
MAUDE reports naming product code MNR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 124 | 2 | 1 |
| 2008 | 14 | 118 | 0 | 0 |
| 2009 | 8 | 89 | 1 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 9 | 90 | 1 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 4 | 161 | 0 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 4 | 229 | 0 | 4 |
| 2016 | 3 | 281 | 0 | 10 |
| 2017 | 4 | 275 | 0 | 4 |
| 2018 | 3 | 147 | 0 | 2 |
| 2019 | 8 | 383 | 0 | 3 |
| 2020 | 5 | 192 | 0 | 5 |
| 2021 | 3 | 137 | 1 | 5 |
| 2022 | 7 | 266 | 0 | 4 |
| 2023 | 6 | 183 | 0 | 13 |
| 2024 | 6 | 217 | 0 | 11 |
| 2025 | 10 | 165 | 0 | 43 |
| 2026 | 5 | 227 | 1 | — |
What is it indicated for?
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…
Read the full statement (130 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983572 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983572: Simon Multichannel Recording System, Model 5500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983572
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026