510(k) · Cleared
ClearedBresoDX1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bresotec, Inc. · MNR Ventilatory Effort Recorder
Cleared on Dec 21, 2022 as substantially equivalent to K110486 (Novasom, Inc., 2011) after a 351-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Dec 21, 2022
- Review
- 351 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K910870 (1991). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK910870 Edentec Model 3711 Digital RecorderEdentec Corp. · 1991
- 4 generations backK963597 Silent Night ILocal Silence, Inc. · 1997
- 3 generations backK981034 Silent Night IISleep Solutions, Inc. · 1998
- 2 generations backK000253 Silent Night VSleep Solutions, Inc. · 2000
- 1 generation backK110486 AccusomNovasom, Inc. · 2011
- This deviceK220012 BresoDX1Bresotec, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K910870 | Edentec Model 3711 Digital Recorder | Edentec Corp. | 1991 | — |
| −4 | K963597 | Silent Night I | Local Silence, Inc. | 1997 | — |
| −3 | K981034 | Silent Night II | Sleep Solutions, Inc. | 1998 | — |
| −2 | K000253 | Silent Night V | Sleep Solutions, Inc. | 2000 | — |
| −1 | K110486 | Accusom | Novasom, Inc. | 2011 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K110486 | AccusomSummary page 4…Classification Name: 21 C.F.R. 868.2375, Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Predicate Device: ACCUSOM manufactured by NovaSom, Inc. (K110486) Referenced Devices: WatchPat200U, manufactured by Itamar Medical, Ltd. (K203839), and AcuPebble SA100 manufactured by Acurable… | 2011 |
| † | K203839 | WatchPAT200U (WP200U) | 2022 |
| † | K210480 | AcuPebble SA | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 5 companies; a new generation was cleared every 5.4 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
BresoDX1 is indicated for use as an aid in the diagnosis of moderate to severe sleep apnea in adult patients. BresoDX1 records a patient’s physiological signals during sleep and scores apneas and hypopneas. BresoDX1 is intended to be used in the home and clinic settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220012: BresoDX1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220012
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