510(k) · Cleared
ClearedAccusom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novasom, Inc. · MNR Ventilatory Effort Recorder
Cleared on Aug 12, 2011 as substantially equivalent to K000253 (Sleep Solutions, Inc., 2000) after a 171-day review. Its family tree reaches back 4 generations to 1991. 1 later device descends from it.
- Decided
- Aug 12, 2011
- Review
- 171 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K910870 (1991). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK910870 Edentec Model 3711 Digital RecorderEdentec Corp. · 1991
- 3 generations backK963597 Silent Night ILocal Silence, Inc. · 1997
- 2 generations backK981034 Silent Night IISleep Solutions, Inc. · 1998
- 1 generation backK000253 Silent Night VSleep Solutions, Inc. · 2000
- This deviceK110486 AccusomNovasom, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK220012 BresoDX1Bresotec, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K220012BresoDX1Bresotec, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K910870 | Edentec Model 3711 Digital Recorder | Edentec Corp. | 1991 | — |
| −3 | K963597 | Silent Night I | Local Silence, Inc. | 1997 | — |
| −2 | K981034 | Silent Night II | Sleep Solutions, Inc. | 1998 | — |
| −1 | K000253 | Silent Night V | Sleep Solutions, Inc. | 2000 | — |
| 0 (this device) | K110486 | Accusom | Novasom, Inc. | 2011 | — |
| +1 | K220012 | BresoDX1 | Bresotec, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K000253 | Silent Night VSummary page 1…cation: Class 11per 21 CFR 868.2375, Ventilatory Effort Recorder, Product Code MNR Legally Marketed Predicate Silent Night V (K000253), manufactured by NovaSom, Inc. Device: (formerly Sleep Solutions, Inc.) Description of New ACCUSOM Device: The… | 2000 |
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 |
|---|---|---|---|
| K220012 | BresoDX1 | 2022 | 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?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K220012 (Bresotec, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K000253.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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?
The ACCUSOM device is indicated for use in the diagnostic evaluation of adults with
possible sleep apnea. The ACCUSOM can score obstructive apneas, which includes
mixed apneas.
The ACCUSOM device is intended for use in the home and clinic setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110486 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110486: Accusom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110486
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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