510(k) · Cleared
Recalled · 2026Embletta MPR
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 Feb 21, 2013 as substantially equivalent to K041904 (Medcare Flaga, 2004) and 1 other predicate after a 188-day review. Its family tree reaches back 6 generations to 1992. 27 later devices descend from it. It has been recalled once.
- Decided
- Feb 21, 2013
- Review
- 188 days
- Class
- Class II
- Product code
- MNR
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K913396 (1992). 27 ancestors in all. 27 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 5 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 4 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 3 generations backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- 2 generations backK041904 Compass F10 SystemMedcare Flaga · 2004
- 1 generation backK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
- This deviceK122516 Embletta MPREmbla Systems · 2013
- Descendant · cites it directly · 20 of its ownK161579 Watch-PAT200UItamar Medical, Ltd. · 2017
- Descendant · 2 generations on · 12 of its ownK180775 Watch-PAT300Itamar Medical, Ltd. · 2018
- Descendant · 2 generations on · 5 of its ownK191031 NightOwlEctosense NV · 2020
- Descendant · 3 generations on · 5 of its ownK183559 WatchPAT ONEItamar Medical, Ltd. · 2019
- Descendant · 4 generations on · 4 of its ownK220095 ANNE SleepSibel, Inc. · 2022
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K161579Watch-PAT200UItamar Medical, Ltd. · 2017 · cites it directly20descendants
- K180775Watch-PAT300Itamar Medical, Ltd. · 2018 · 2 generations on12descendants
- K191031NightOwlEctosense NV · 2020 · 2 generations on5descendants
- K183559WatchPAT ONEItamar Medical, Ltd. · 2019 · 3 generations on5descendants
- K220095ANNE SleepSibel, Inc. · 2022 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −5 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −4 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −3 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| −2 | K041904 | Compass F10 System | Medcare Flaga | 2004 | — |
| −1 | K073682 | Embletta Gold | Embla Systems, Inc. | 2008 | 1 |
| 0 (this device) | K122516 | Embletta MPR | Embla Systems | 2013 | — |
| +1 | K161579 | Watch-PAT200U | Itamar Medical, Ltd. | 2017 | — |
| +2 | K180775 | Watch-PAT300 | Itamar Medical, Ltd. | 2018 | — |
| +2 | K191031 | NightOwl | Ectosense NV | 2020 | — |
| +3 | K183559 | WatchPAT ONE | Itamar Medical, Ltd. | 2019 | — |
| +4 | K220095 | ANNE Sleep | Sibel, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 6 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 1 | 0 |
| 2025 | 7 | 0 |
| 2026 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K041904 | Compass F10 SystemSummary page 1…MNR F. Device Class: Class 11 PREDICATE DEVICES A. Trade Name: Embla Compass, 5 10(k) Number: K041 904 B. Trade Name: Embletta Gold, 5 10(k) Number: K073682… | 2004 |
| * | K073682 | Embletta GoldSummary page 1…PREDICATE DEVICES A. Trade Name: Embla Compass, 5 10(k) Number: K041 904 B. Trade Name: Embletta Gold, 5 10(k) Number: K073682 Page]1 of? Embla Embletta MPR 5 1… | 2008 |
What descends from it? (27)
See all 273 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 29, 2026 | Not classified | Z-0319-2027 | Component change control | The device may be unable to correctly format its internal memory. When the internal memory cannot be correctly formatted, previously recorded studies may remain on the device and may be updated with incorrect patient information from a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 7 companies; a new generation was cleared every 4.1 years on median.
- 2 of the 27 ancestors have a recall of any class.
- Of its descendants, K161579 (Itamar Medical, Ltd., 2017) has gone furthest, with 20 descendants of its own.
- 3 other devices also cite its predicate K041904.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Embletta MPR is a digital recording device designed to be used under the direction of a physician or trained technician but may be applied by a layperson. The Embletta MPR records multiple physiological parameters from a sleeping patient for the purpose of simultaneous or subsequent display of the parameters. The displayed data assists in the identification of sleep-related medical disorders by trained personnel. The Embletta MPR is intended to be…
Read the full statement (129 words)
The Embletta MPR is a digital recording device designed to be used under the direction of a physician or trained technician but may be applied by a layperson. The Embletta MPR records multiple physiological parameters from a sleeping patient for the purpose of simultaneous or subsequent display of the parameters. The displayed data assists in the identification of sleep-related medical disorders by trained personnel.
The Embletta MPR is intended to be used for adult and pediatric (excluding infants and neonatal) studies. The device is not equipped with alarms and is not intended to be used as a monitor.
The intended environments include any clean, dry, dust free environment suitable for a patient's relative comfort.
The device does not monitor or diagnose the patient and does not issue any alarms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122516: Embletta MPR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122516
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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