510(k) · Cleared
ClearedMATRx plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zephyr Sleep Technologies · MNR Ventilatory Effort Recorder
Cleared on Aug 24, 2020 as substantially equivalent to K191925 (Zephyr Sleep Technologies, 2019) after a 160-day review. Its family tree reaches back 13 generations to 1992.
- Decided
- Aug 24, 2020
- Review
- 160 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K913396 (1992). 47 ancestors in all, the oldest K893221 (1990). No later device cites it as a predicate yet.
- Root · 13 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 9 generations between
- 3 generations backK163665 MATRx plusZephyr Sleep Technologies · 2017
- 2 generations backK181996 MATRx PlusZephyr Sleep Technologies · 2018
- 1 generation backK191925 MATRx PlusZephyr Sleep Technologies · 2019
- This deviceK200695 MATRx plusZephyr Sleep Technologies · 2020
Show all 13 generations
- Root · 13 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 12 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 11 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 10 generations backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- 9 generations backK040576 Micromesam Basic-SetMap Medizintechnik Fur Arzt Und Patient GmbH · 2004
- 8 generations backK061405 Apnealink, Model 22302Resmed Germany, Inc. · 2006
- 7 generations backK070263 ApnealinkResmed Germany, Inc. · 2007
- 6 generations backK083575 Apnealink Plus, Model: 22328Resmed Germany, Inc. · 2009
- 5 generations backK131932 Apnealink ProResmed Germany, Inc. · 2013
- 4 generations backK143272 ApneaLink AirResmed Germany, Inc. · 2015
- 3 generations backK163665 MATRx plusZephyr Sleep Technologies · 2017
- 2 generations backK181996 MATRx PlusZephyr Sleep Technologies · 2018
- 1 generation backK191925 MATRx PlusZephyr Sleep Technologies · 2019
- This deviceK200695 MATRx plusZephyr Sleep Technologies · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −12 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −11 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −10 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| −9 | K040576 | Micromesam Basic-Set | Map Medizintechnik Fur Arzt Und Patient GmbH | 2004 | — |
| −8 | K061405 | Apnealink, Model 22302 | Resmed Germany, Inc. | 2006 | — |
| −7 | K070263 | Apnealink | Resmed Germany, Inc. | 2007 | — |
| −6 | K083575 | Apnealink Plus, Model: 22328 | Resmed Germany, Inc. | 2009 | — |
| −5 | K131932 | Apnealink Pro | Resmed Germany, Inc. | 2013 | — |
| −4 | K143272 | ApneaLink Air | Resmed Germany, Inc. | 2015 | — |
| −3 | K163665 | MATRx plus | Zephyr Sleep Technologies | 2017 | — |
| −2 | K181996 | MATRx Plus | Zephyr Sleep Technologies | 2018 | — |
| −1 | K191925 | MATRx Plus | Zephyr Sleep Technologies | 2019 | — |
| 0 (this device) | K200695 | MATRx plus | Zephyr Sleep Technologies | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K191925 | MATRx PlusSummary page 4…assification Code: Class II Product Code: QCJ, MNR Primary Predicate: MATRx plus (K191925) Device Description: MATRx plus is a ventilatory effort recorder and closed loop auto-titration device for oral appliances. MAT… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 4 of the 47 ancestors have a recall of any class.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 MATRx plus is indicated for use by a lay person in a home and hospital use under the direction of a Health Care Professional (HCP). MATRx plus records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort and body position during sleep. MATRx plus uses these recordings to produce a report for the HCP that may aid in the diagnosis and assessment of sleep disordered breathing for adult…
Read the full statement (181 words)
The MATRx plus is indicated for use by a lay person in a home and hospital use under the direction of a Health Care Professional (HCP).
MATRx plus records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort and body position during sleep.
MATRx plus uses these recordings to produce a report for the HCP that may aid in the diagnosis and assessment of sleep disordered breathing for adult patients.
The MATRx plus device may also be used with an automated mandibular positioner that uses feedback control to record changes in the patient’s respiratory status related to repositioning of the mandible during an overnight study.
MATRx plus uses these recordings to produce a report for the HCP that can be used to prospectively identify patients with mild to moderate obstructive sleep apnea who may be suitable for oral appliance therapy and to recommend a target mandibular position.
The use of the device does not replace the need for follow-up testing to determine the initial and ongoing effectiveness of the therapy as recommended by clinical practice guidelines.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200695 · printed Nov 5, 2026
Cite this page
510(k) Report. “K200695: MATRx plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K200695
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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