510(k) · Cleared
ClearedUltima Snoring Mike, Model 0540
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Braebon Medical Corp. · MNR Ventilatory Effort Recorder
Cleared on Aug 7, 2002 after a 189-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 25 later devices descend from it.
- Decided
- Aug 7, 2002
- Review
- 189 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 0
25 later devices descend from it, 2 citing it directly.
- This deviceK020312 Ultima Snoring Mike, Model 0540Braebon Medical Corp. · 2002
- Descendant · cites it directly · 23 of its ownK102567 Watch-Pat 200S-3 (WP200S-3)Itamar Medical, Ltd. · 2011
- Descendant · 2 generations on · 22 of its ownK133859 Watch-PAT200U (WP200U)Itamar Medical, Ltd. · 2014
- Descendant · 3 generations on · 20 of its ownK161579 Watch-PAT200UItamar Medical, Ltd. · 2017
- Descendant · 4 generations on · 12 of its ownK180775 Watch-PAT300Itamar Medical, Ltd. · 2018
- Descendant · 4 generations on · 5 of its ownK191031 NightOwlEctosense NV · 2020
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K102567Watch-Pat 200S-3 (WP200S-3)Itamar Medical, Ltd. · 2011 · cites it directly23descendants
- K133859Watch-PAT200U (WP200U)Itamar Medical, Ltd. · 2014 · 2 generations on22descendants
- K161579Watch-PAT200UItamar Medical, Ltd. · 2017 · 3 generations on20descendants
- K180775Watch-PAT300Itamar Medical, Ltd. · 2018 · 4 generations on12descendants
- K191031NightOwlEctosense NV · 2020 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020312 | Ultima Snoring Mike, Model 0540 | Braebon Medical Corp. | 2002 | — |
| +1 | K102567 | Watch-Pat 200S-3 (WP200S-3) | Itamar Medical, Ltd. | 2011 | — |
| +2 | K133859 | Watch-PAT200U (WP200U) | Itamar Medical, Ltd. | 2014 | — |
| +3 | K161579 | Watch-PAT200U | Itamar Medical, Ltd. | 2017 | — |
| +4 | K180775 | Watch-PAT300 | Itamar Medical, Ltd. | 2018 | — |
| +4 | K191031 | NightOwl | Ectosense NV | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 6 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (25)
See all 252 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K102567 (Itamar Medical, Ltd., 2011) has gone furthest, with 23 descendants of its own.
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?
The Ultima Snoring Mike provides a qualitative measure of snoring for recording onto an FDA-cleared data acquisition system.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K020312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020312: Ultima Snoring Mike, Model 0540.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020312
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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