510(k) · Cleared
ClearedNox RIP Belts & Cables
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nox Medical Ehf · MNR Ventilatory Effort Recorder
Cleared on Nov 6, 2015 as substantially equivalent to K124062 (Nox Medical, 2013) after a 169-day review. Its family tree reaches back 9 generations to 1991. 2 later devices descend from it.
- Decided
- Nov 6, 2015
- Review
- 169 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K910772 (1991). 29 ancestors in all, the oldest K893221 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 5 generations between
- 3 generations backK043359 4100 Patient Oximeter ModuleNonin Medical, Inc. · 2005
- 2 generations backK082113 Nox T3, Noxturnal (PC Application)Nox Medical · 2008 · Recalled
- 1 generation backK124062 QDC-Pro, and Nox-RipNox Medical · 2013
- This deviceK151361 Nox RIP Belts & CablesNox Medical Ehf · 2015
- Descendant · cites it directly · 0 of its ownK260949 Disposable Belts for Polysomnography (CNSAC)CNSAC Medshop GmbH · 2026
- Descendant · cites it directly · 0 of its ownK171304 Maxxi Rip SensorNeurovirtual USA, Inc. · 2019
Show all 9 generations
- Root · 9 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 8 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 7 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 6 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 5 generations backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- 4 generations backK041156 Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc. · 2004 · Recalled
- 3 generations backK043359 4100 Patient Oximeter ModuleNonin Medical, Inc. · 2005
- 2 generations backK082113 Nox T3, Noxturnal (PC Application)Nox Medical · 2008 · Recalled
- 1 generation backK124062 QDC-Pro, and Nox-RipNox Medical · 2013
- This deviceK151361 Nox RIP Belts & CablesNox Medical Ehf · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −8 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −7 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −6 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −5 | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| −4 | K041156 | Avant Digital Pulse Oximetry System, Models 4000, 4001 | Nonin Medical, Inc. | 2004 | 1 |
| −3 | K043359 | 4100 Patient Oximeter Module | Nonin Medical, Inc. | 2005 | — |
| −2 | K082113 | Nox T3, Noxturnal (PC Application) | Nox Medical | 2008 | 1 |
| −1 | K124062 | QDC-Pro, and Nox-Rip | Nox Medical | 2013 | — |
| 0 (this device) | K151361 | Nox RIP Belts & Cables | Nox Medical Ehf | 2015 | — |
| +1 | K260949 | Disposable Belts for Polysomnography (CNSAC) | CNSAC Medshop GmbH | 2026 | — |
| +1 | K171304 | Maxxi Rip Sensor | Neurovirtual USA, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 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 |
|---|---|---|
| 2019 | 1 | 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? (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 |
|---|---|---|---|
| * | K124062 | QDC-Pro, and Nox-RipSummary page 7…Section 5 – Page 1 of 12 Predicate Device QDC-PRO AND NOX-RIP from Nox Medical ehf Product Code: MNR 510(k) Number: K124062 This predicate has not been subject to a design-related recall. Note1: Please note that the Nox RIP Belts will be reg… | 2013 |
What descends from it? (2)
2 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 24 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 29 ancestors have a recall of any class.
- Of its descendants, K260949 (CNSAC Medshop GmbH, 2026) has gone furthest, with 0 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. 2015, 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 RIP Belts are intended for measuring of respiratory effort signals. They function as accessories for sleep/polysomnography (PSG) systems. The Nox RIP Belts are indicated for use on patients greater than 2 years of age. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient´s home. The RIP Belt Cables are intended to interconnect Nox RIP belts (respiratory effort…
Read the full statement (187 words)
The Nox RIP Belts are intended for measuring of respiratory effort signals. They function as accessories for sleep/polysomnography (PSG) systems.
The Nox RIP Belts are indicated for use on patients greater than 2 years of age.
The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient´s home.
The RIP Belt Cables are intended to interconnect Nox RIP belts (respiratory effort sensors) and Nox sleep devices, to allow measuring of respiratory effort signals.
The RIP Belt Cables are indicated for use on patients greater than 2 years of age.
The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient´s home.
The Third Party RIP Belt Cables are intended to allow measuring of respiratory effort signals by interconnecting Nox RIP belts (respiratory effort sensors) and sleep devices with oscillation circuitry capable of measuring inductance between 1 and 5 μH.
The Third Party RIP Belt Cables are indicated for use on patients greater than 2 years of age.
The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient´s home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151361: Nox RIP Belts & Cables.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151361
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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