510(k) · Cleared
ClearedApnealink
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resmed Germany, Inc. · MNR Ventilatory Effort Recorder
Cleared on Jun 15, 2007 as substantially equivalent to K061405 (Resmed Germany, Inc., 2006) after a 140-day review. Its family tree reaches back 6 generations to 1992. 29 later devices descend from it.
- Decided
- Jun 15, 2007
- Review
- 140 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K913396 (1992). 14 ancestors in all. 29 later devices descend from it, 2 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 backK040576 Micromesam Basic-SetMap Medizintechnik Fur Arzt Und Patient GmbH · 2004
- 1 generation backK061405 Apnealink, Model 22302Resmed Germany, Inc. · 2006
- This deviceK070263 ApnealinkResmed Germany, Inc. · 2007
- Descendant · cites it directly · 27 of its ownK083575 Apnealink Plus, Model: 22328Resmed Germany, Inc. · 2009
- Descendant · 2 generations on · 8 of its ownK140124 S9 EloueraResmed Corp · 2014
- Descendant · 2 generations on · 8 of its ownK132371 Easycare OnlineResmed, Ltd. · 2013
- Descendant · 2 generations on · 8 of its ownK131932 Apnealink ProResmed Germany, Inc. · 2013
- Descendant · 3 generations on · 7 of its ownK143272 ApneaLink AirResmed Germany, Inc. · 2015
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K083575Apnealink Plus, Model: 22328Resmed Germany, Inc. · 2009 · cites it directly27descendants
- K140124S9 EloueraResmed Corp · 2014 · 2 generations on8descendants
- K132371Easycare OnlineResmed, Ltd. · 2013 · 2 generations on8descendants
- K131932Apnealink ProResmed Germany, Inc. · 2013 · 2 generations on8descendants
- K143272ApneaLink AirResmed Germany, Inc. · 2015 · 3 generations on7descendants
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 | K040576 | Micromesam Basic-Set | Map Medizintechnik Fur Arzt Und Patient GmbH | 2004 | — |
| −1 | K061405 | Apnealink, Model 22302 | Resmed Germany, Inc. | 2006 | — |
| 0 (this device) | K070263 | Apnealink | Resmed Germany, Inc. | 2007 | — |
| +1 | K083575 | Apnealink Plus, Model: 22328 | Resmed Germany, Inc. | 2009 | — |
| +2 | K140124 | S9 Elouera | Resmed Corp | 2014 | — |
| +2 | K132371 | Easycare Online | Resmed, Ltd. | 2013 | — |
| +2 | K131932 | Apnealink Pro | Resmed Germany, Inc. | 2013 | — |
| +3 | K143272 | ApneaLink Air | Resmed Germany, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 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? (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 |
|---|---|---|---|
| * | K061405 | Apnealink, Model 22302Summary page 1…atory Effort Recorder Common/Usual Name Ventilatory Effort Recorder Proprietary Name ApneaLink Predicate Devices ApneaLink (K061405) Reason for submission Expanded Indications 1 6 th January, 2007 C4060… | 2006 |
What descends from it? (29)
See all 292 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?
- The line of descent spans 15 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K083575 (Resmed Germany, Inc., 2009) has gone furthest, with 27 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. 2007, 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?
ApneaLink records patient respiratory nasal pressure and blood oxygen saturation during sleep. The device is intended for use as a screening device to determine the need for further clinical diagnosis based on the patient's test score. ApneaLink reports apneas, hypopneas, flow limitation, snoring, SpO2 and the probability of Cheyne-Stokes respiration breathing patterns within the recording.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070263 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070263: Apnealink.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070263
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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