510(k) · Cleared
Recalled · Class II · 2021Nox T3, Noxturnal (PC Application)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nox Medical · MNR Ventilatory Effort Recorder
Cleared on Nov 7, 2008 as substantially equivalent to K024322 (Medcare Flaga, 2003) and 2 other predicates after a 102-day review. Its family tree reaches back 7 generations to 1991. 17 later devices descend from it. It has been recalled once.
- Decided
- Nov 7, 2008
- Review
- 102 days
- Class
- Class II
- Product code
- MNR
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 7 generations to K910772 (1991). 26 ancestors in all, the oldest K893221 (1990). 17 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 6 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 5 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 4 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 3 generations backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- 2 generations backK041156 Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc. · 2004 · Recalled
- 1 generation backK043359 4100 Patient Oximeter ModuleNonin Medical, Inc. · 2005
- This deviceK082113 Nox T3, Noxturnal (PC Application)Nox Medical · 2008
- Descendant · cites it directly · 7 of its ownK143272 ApneaLink AirResmed Germany, Inc. · 2015
- Descendant · 2 generations on · 3 of its ownK163665 MATRx plusZephyr Sleep Technologies · 2017
- Descendant · cites it directly · 3 of its ownK124062 QDC-Pro, and Nox-RipNox Medical · 2013
- Descendant · cites it directly · 3 of its ownK120462 Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep…Inovise Medical, Inc. · 2012
- Descendant · 3 generations on · 2 of its ownK181996 MATRx PlusZephyr Sleep Technologies · 2018
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K143272ApneaLink AirResmed Germany, Inc. · 2015 · cites it directly7descendants
- K163665MATRx plusZephyr Sleep Technologies · 2017 · 2 generations on3descendants
- K124062QDC-Pro, and Nox-RipNox Medical · 2013 · cites it directly3descendants
- K120462Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…Inovise Medical, Inc. · 2012 · cites it directly3descendants
- K181996MATRx PlusZephyr Sleep Technologies · 2018 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −6 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −5 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −4 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −3 | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| −2 | K041156 | Avant Digital Pulse Oximetry System, Models 4000, 4001 | Nonin Medical, Inc. | 2004 | 1 |
| −1 | K043359 | 4100 Patient Oximeter Module | Nonin Medical, Inc. | 2005 | — |
| 0 (this device) | K082113 | Nox T3, Noxturnal (PC Application) | Nox Medical | 2008 | — |
| +1 | K143272 | ApneaLink Air | Resmed Germany, Inc. | 2015 | — |
| +2 | K163665 | MATRx plus | Zephyr Sleep Technologies | 2017 | — |
| +1 | K124062 | QDC-Pro, and Nox-Rip | Nox Medical | 2013 | — |
| +1 | K120462 | Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep… | Inovise Medical, Inc. | 2012 | — |
| +3 | K181996 | MATRx Plus | Zephyr Sleep Technologies | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K024322 | Embla N7000Summary page 1…Anesthesiology Predicate Devices Embla N7000 from Medcare Flaga Product Code: MNR 510(k) Number: K024322 Compass M10 from Medcare Flaga Product Code: MNR 510(k) Number… | 2003 |
| * | K041724 | Compass M10 SystemSummary page 1…510(k) Number: K024322 Compass M10 from Medcare Flaga Product Code: MNR 510(k) Number: K041724 4100 Patient Oximeter Module from Nonin Medical Inc. Product Code: DQA… | 2004 |
| * | K043359 | 4100 Patient Oximeter ModuleSummary page 1…Number: K041724 4100 Patient Oximeter Module from Nonin Medical Inc. Product Code: DQA 510(k) Number: K043359 510(k) Summary Section 5 - Page 1 of 8 === Page… | 2005 |
What descends from it? (17)
See all 174 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 7, 2021 | Class II | Z-0031-2022 | Finished device change control | Error in the device firmware results in the inaccurate detection of device position. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 26 ancestors have a recall of any class.
- Of its descendants, K143272 (Resmed Germany, Inc., 2015) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K024322.
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 Nox T3 device is intended for ambulatory recording of physiological signals during
sleep. The recorded signals are then downloaded to a PC where the signals can be
viewed and analyzed by use of the Nox T3 application (Noxturnal). The Nox T3 system
is indicated for use in patients greater than 2 years of age.
The Nox T3 system is NOT intended for any patient monitoring or automatic diagnosis.
The intended environments are hospitals, institutions, sleep centers, sleep clinics, or
other test environments, including patient's home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082113: Nox T3, Noxturnal (PC Application).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082113
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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