510(k) · Cleared
Recalled · Class II · 2013Embletta Gold
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Embla Systems, Inc. · MNR Ventilatory Effort Recorder
Cleared on Aug 8, 2008 as substantially equivalent to K041904 (Medcare Flaga, 2004) and 3 other predicates after a 224-day review. Its family tree reaches back 5 generations to 1992. 41 later devices descend from it. It has been recalled once.
- Decided
- Aug 8, 2008
- Review
- 224 days
- Class
- Class II
- Product code
- MNR
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 5 generations to K913396 (1992). 26 ancestors in all. 41 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 4 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 3 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 2 generations backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- 1 generation backK041904 Compass F10 SystemMedcare Flaga · 2004
- This deviceK073682 Embletta GoldEmbla Systems, Inc. · 2008
- Descendant · cites it directly · 27 of its ownK122516 Embletta MPREmbla Systems · 2013 · Recalled
- Descendant · 2 generations on · 20 of its ownK161579 Watch-PAT200UItamar Medical, Ltd. · 2017
- Descendant · 3 generations on · 12 of its ownK180775 Watch-PAT300Itamar Medical, Ltd. · 2018
- Descendant · cites it directly · 7 of its ownK090273 Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai…Kai Sensors, Inc. · 2009
- Descendant · 3 generations on · 5 of its ownK191031 NightOwlEctosense NV · 2020
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K122516Embletta MPREmbla Systems · 2013 · cites it directly27descendants
- K161579Watch-PAT200UItamar Medical, Ltd. · 2017 · 2 generations on20descendants
- K180775Watch-PAT300Itamar Medical, Ltd. · 2018 · 3 generations on12descendants
- K090273Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100Kai Sensors, Inc. · 2009 · cites it directly7descendants
- K191031NightOwlEctosense NV · 2020 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −4 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −3 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −2 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| −1 | K041904 | Compass F10 System | Medcare Flaga | 2004 | — |
| 0 (this device) | K073682 | Embletta Gold | Embla Systems, Inc. | 2008 | — |
| +1 | K122516 | Embletta MPR | Embla Systems | 2013 | 1 |
| +2 | K161579 | Watch-PAT200U | Itamar Medical, Ltd. | 2017 | — |
| +3 | K180775 | Watch-PAT300 | Itamar Medical, Ltd. | 2018 | — |
| +1 | K090273 | Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot… | Kai Sensors, Inc. | 2009 | — |
| +3 | K191031 | NightOwl | Ectosense NV | 2020 | — |
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 |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 9 | 0 |
| 2026 | 5 | 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? (4)
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…F. Device Class: Class 11 G. Classification Panel: Anesthesiology PREDICATE DEVICES A. Trade Name: Compass FlIO System, 5 10(k) Number: K041904 B. Trade Name: Somt6 System, 510(k) Number: K021 176 C. Trade Name: Medipalm -20, 510(k) Number: K031202 D. Trade… | 2004 |
| * | K021176 | Compumedics Somte SystemSummary page 1…ssification Panel: Anesthesiology PREDICATE DEVICES A. Trade Name: Compass FlIO System, 5 10(k) Number: K041904 B. Trade Name: Somt6 System, 510(k) Number: K021 176 C. Trade Name: Medipalm -20, 510(k) Number: K031202 D. Trade Name: Crystal 20 Monitors, 5 10(k) Number: K042039… | 2003 |
| * | K031202 | Medipalm-20Summary page 1…A. Trade Name: Compass FlIO System, 5 10(k) Number: K041904 B. Trade Name: Somt6 System, 510(k) Number: K021 176 C. Trade Name: Medipalm -20, 510(k) Number: K031202 D. Trade Name: Crystal 20 Monitors, 5 10(k) Number: K042039 Pagel1of4… | 2003 |
| * | K042039 | Family of Crystal 20 Monitors Model #CS20-600,900,1300,1400,2400 & 120Summary page 1…B. Trade Name: Somt6 System, 510(k) Number: K021 176 C. Trade Name: Medipalm -20, 510(k) Number: K031202 D. Trade Name: Crystal 20 Monitors, 5 10(k) Number: K042039 Pagel1of4 Traditional 510(k) Notification for Embla Embletta GOLDTM Rec… | 2004 |
What descends from it? (41)
See all 413 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 |
|---|---|---|---|---|
| Apr 24, 2013 | Class II | Z-1532-2013 | Nonconforming Material/Component | Calibration error for Embla Embletta Gold units calibrated through service center between June 15, 2012 to February 27, 2013. This calibration error could cause a clinician to over titrate the patient and prescribe a therapy pressure… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 26 ancestors has a recall of any class.
- Of its descendants, K122516 (Embla Systems, 2013) has gone furthest, with 27 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. 2008, 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 Gold is a digital recording device designed to be used under the direction of a physician or trained technician but applied by a layperson. The Embletta Gold records multiple physiological parameters 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 Gold is intended to be used for adult and pediatric…
Read the full statement (112 words)
The Embletta Gold is a digital recording device designed to be used under the direction of a physician or trained technician but applied by a layperson. The Embletta Gold records multiple physiological parameters 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 Gold is intended to be used for adult and pediatric (excluding neonatal and infant) studies. Note the recorder is not equipped with an alarm device and is not intended to be used as a life monitor.
The intended environments include any clean, dry, dust free environment suitable for a patient's relative comfort.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073682 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073682: Embletta Gold.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073682
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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