510(k) · Cleared
ClearedApnealink Plus, Model: 22328
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 Mar 19, 2009 as substantially equivalent to K070263 (Resmed Germany, Inc., 2007) and 1 other predicate after a 106-day review. Its family tree reaches back 7 generations to 1992. 27 later devices descend from it.
- Decided
- Mar 19, 2009
- Review
- 106 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K913396 (1992). 25 ancestors in all, the oldest K914085 (1991). 27 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 6 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 5 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 4 generations backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- 3 generations backK040576 Micromesam Basic-SetMap Medizintechnik Fur Arzt Und Patient GmbH · 2004
- 2 generations backK061405 Apnealink, Model 22302Resmed Germany, Inc. · 2006
- 1 generation backK070263 ApnealinkResmed Germany, Inc. · 2007
- This deviceK083575 Apnealink Plus, Model: 22328Resmed Germany, Inc. · 2009
- Descendant · cites it directly · 8 of its ownK140124 S9 EloueraResmed Corp · 2014
- Descendant · cites it directly · 8 of its ownK132371 Easycare OnlineResmed, Ltd. · 2013
- Descendant · cites it directly · 8 of its ownK131932 Apnealink ProResmed Germany, Inc. · 2013
- Descendant · 2 generations on · 7 of its ownK143272 ApneaLink AirResmed Germany, Inc. · 2015
- Descendant · 2 generations on · 6 of its ownK160836 Menai SystemResmed, Ltd. · 2016
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K140124S9 EloueraResmed Corp · 2014 · cites it directly8descendants
- K132371Easycare OnlineResmed, Ltd. · 2013 · cites it directly8descendants
- K131932Apnealink ProResmed Germany, Inc. · 2013 · cites it directly8descendants
- K143272ApneaLink AirResmed Germany, Inc. · 2015 · 2 generations on7descendants
- K160836Menai SystemResmed, Ltd. · 2016 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −6 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −5 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −4 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| −3 | K040576 | Micromesam Basic-Set | Map Medizintechnik Fur Arzt Und Patient GmbH | 2004 | — |
| −2 | K061405 | Apnealink, Model 22302 | Resmed Germany, Inc. | 2006 | — |
| −1 | K070263 | Apnealink | Resmed Germany, Inc. | 2007 | — |
| 0 (this device) | K083575 | Apnealink Plus, Model: 22328 | Resmed Germany, Inc. | 2009 | — |
| +1 | K140124 | S9 Elouera | Resmed Corp | 2014 | — |
| +1 | K132371 | Easycare Online | Resmed, Ltd. | 2013 | — |
| +1 | K131932 | Apnealink Pro | Resmed Germany, Inc. | 2013 | — |
| +2 | K143272 | ApneaLink Air | Resmed Germany, Inc. | 2015 | — |
| +2 | K160836 | Menai System | Resmed, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K070263 | ApnealinkSummary page 1…order Common/Usual Name Ventilatory Effort Recorder Proprietary Name Apneal-ink Plus Predicate Devices Apneal-ink (K070263) Respironics Stardust II (K02 1845) Reason for submission Expanded Indications… | 2007 |
| * | K021845 | Stardust II, Model 1011176Summary page 1…Proprietary Name Apneal-ink Plus Predicate Devices Apneal-ink (K070263) Respironics Stardust II (K02 1845) Reason for submission Expanded Indications 2 8 th November, 2008 C39506… | 2004 |
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)
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 17 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 25 ancestors has a recall of any class.
- Of its descendants, K140124 (Resmed Corp, 2014) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K070263.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 ApneaLink TM Plus device is indicated for use by Health Care Professionals (HCP), where it may aid in the diagnosis of sleep disordered breathing for adult patients. ApneaLink Plus records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse and respiratory effort during sleep. The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing or for further clinical investigation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083575 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083575: Apnealink Plus, Model: 22328.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083575
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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