510(k) · Cleared
ClearedMdrive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Embla Systems · MNR Ventilatory Effort Recorder
Cleared on Aug 31, 2011 as substantially equivalent to K024322 (Medcare Flaga, 2003) after a 71-day review. Its family tree reaches back 2 generations to 1999. 2 later devices descend from it.
- Decided
- Aug 31, 2011
- Review
- 71 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K992283 (1999). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK992283 Artisan Acquisition System for Eeg and PolysomnographyAirsep Corp. · 1999
- 1 generation backK024322 Embla N7000Medcare Flaga · 2003
- This deviceK111742 MdriveEmbla Systems · 2011
- Descendant · cites it directly · 1 of its ownK180290 Natus Brain Monitor AmplifierNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2018 · Recalled
- Descendant · 2 generations on · 0 of its ownK193159 NeuroAmp II, NeuroAmp II.5sCorscience GmbH & Co. KG · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992283 | Artisan Acquisition System for Eeg and Polysomnography | Airsep Corp. | 1999 | — |
| −1 | K024322 | Embla N7000 | Medcare Flaga | 2003 | — |
| 0 (this device) | K111742 | Mdrive | Embla Systems | 2011 | — |
| +1 | K180290 | Natus Brain Monitor Amplifier | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018 | 1 |
| +2 | K193159 | NeuroAmp II, NeuroAmp II.5s | Corscience GmbH & Co. KG | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K024322 | Embla N7000Summary page 1…21 CFR 868.2375 E. Product Code: MNR F. Device Class: Class 11 PREDICATE DEVICES A. Trade Name: Embla N7000, 5 10(k) Number: K024322 Page 20 of 26 Special 510(k) Notification for Embla N7… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180290 | Natus Brain Monitor Amplifier | 2018 | 1 |
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 12 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K180290 (Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), 2018) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K024322.
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 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/K111742 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111742: Mdrive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111742
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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