510(k) · Cleared
ClearedEmbla N7000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcare Flaga · MNR Ventilatory Effort Recorder
Cleared on Oct 27, 2003 as substantially equivalent to K992283 (Airsep Corp., 1999) after a 305-day review. Its family tree reaches back 1 generation to 1999. 113 later devices descend from it.
- Decided
- Oct 27, 2003
- Review
- 305 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992283 (1999). 113 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK992283 Artisan Acquisition System for Eeg and PolysomnographyAirsep Corp. · 1999
- This deviceK024322 Embla N7000Medcare Flaga · 2003
- Descendant · cites it directly · 54 of its ownK041904 Compass F10 SystemMedcare Flaga · 2004
- Descendant · 2 generations on · 41 of its ownK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
- Descendant · cites it directly · 41 of its ownK041724 Compass M10 SystemMedcare Flaga · 2004
- Descendant · 2 generations on · 30 of its ownK061405 Apnealink, Model 22302Resmed Germany, Inc. · 2006
- Descendant · 3 generations on · 29 of its ownK070263 ApnealinkResmed Germany, Inc. · 2007
Showing 5 of 113 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 113 · See all- K041904Compass F10 SystemMedcare Flaga · 2004 · cites it directly54descendants
- K073682Embletta GoldEmbla Systems, Inc. · 2008 · 2 generations on41descendants
- K041724Compass M10 SystemMedcare Flaga · 2004 · cites it directly41descendants
- K061405Apnealink, Model 22302Resmed Germany, Inc. · 2006 · 2 generations on30descendants
- K070263ApnealinkResmed Germany, Inc. · 2007 · 3 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992283 | Artisan Acquisition System for Eeg and Polysomnography | Airsep Corp. | 1999 | — |
| 0 (this device) | K024322 | Embla N7000 | Medcare Flaga | 2003 | — |
| +1 | K041904 | Compass F10 System | Medcare Flaga | 2004 | — |
| +2 | K073682 | Embletta Gold | Embla Systems, Inc. | 2008 | 1 |
| +1 | K041724 | Compass M10 System | Medcare Flaga | 2004 | — |
| +2 | K061405 | Apnealink, Model 22302 | Resmed Germany, Inc. | 2006 | — |
| +3 | K070263 | Apnealink | Resmed Germany, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 7 | 0 |
| 2021 | 5 | 0 |
| 2022 | 8 | 0 |
| 2023 | 6 | 0 |
| 2024 | 5 | 0 |
| 2025 | 15 | 0 |
| 2026 | 14 | 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 |
|---|---|---|---|
| * | K992283 | Artisan Acquisition System for Eeg and PolysomnographySummary page 1…on System For EEG and polysmnography. Airsep Corporation 290 Creekside Drive Buffalo, NY 14228 510(k) Number K992283 Description of the Device The Embla N7000 system is a full polysomnography system with expanded EEG capability. It is… | 1999 |
What descends from it? (113)
See all 1135 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?
- Its one ancestor has no recall.
- Of its descendants, K041904 (Medcare Flaga, 2004) has gone furthest, with 54 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 Embla N7000 is intended for use by a physician or trained technician for the
acquisition of EEG and polysomnography (PSG) signals and transmission of these
signals to a PC during neurophysiologic or sleep examinations. The intended
environments are hospitals, institutions, sleep centers, sleep clinics, or other test
environments.
The use of the Embla N7000 system does not involve any patient monitoring or
diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024322 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024322: Embla N7000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024322
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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