510(k) · Cleared
ClearedDisposable Belts for Polysomnography (CNSAC)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CNSAC Medshop GmbH · MNR Ventilatory Effort Recorder
Cleared on Sep 24, 2026 as substantially equivalent to K151361 (Nox Medical Ehf, 2015) after a 185-day review. Its family tree reaches back 10 generations to 1991.
- Decided
- Sep 24, 2026
- Review
- 185 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K910772 (1991). 30 ancestors in all, the oldest K893221 (1990). No later device cites it as a predicate yet.
- Root · 10 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 6 generations between
- 3 generations backK082113 Nox T3, Noxturnal (PC Application)Nox Medical · 2008 · Recalled
- 2 generations backK124062 QDC-Pro, and Nox-RipNox Medical · 2013
- 1 generation backK151361 Nox RIP Belts & CablesNox Medical Ehf · 2015
- This deviceK260949 Disposable Belts for Polysomnography (CNSAC)CNSAC Medshop GmbH · 2026
Show all 10 generations
- Root · 10 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 9 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 8 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 7 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 6 generations backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- 5 generations backK041156 Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc. · 2004 · Recalled
- 4 generations backK043359 4100 Patient Oximeter ModuleNonin Medical, Inc. · 2005
- 3 generations backK082113 Nox T3, Noxturnal (PC Application)Nox Medical · 2008 · Recalled
- 2 generations backK124062 QDC-Pro, and Nox-RipNox Medical · 2013
- 1 generation backK151361 Nox RIP Belts & CablesNox Medical Ehf · 2015
- This deviceK260949 Disposable Belts for Polysomnography (CNSAC)CNSAC Medshop GmbH · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −9 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −8 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −7 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −6 | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| −5 | K041156 | Avant Digital Pulse Oximetry System, Models 4000, 4001 | Nonin Medical, Inc. | 2004 | 1 |
| −4 | K043359 | 4100 Patient Oximeter Module | Nonin Medical, Inc. | 2005 | — |
| −3 | K082113 | Nox T3, Noxturnal (PC Application) | Nox Medical | 2008 | 1 |
| −2 | K124062 | QDC-Pro, and Nox-Rip | Nox Medical | 2013 | — |
| −1 | K151361 | Nox RIP Belts & Cables | Nox Medical Ehf | 2015 | — |
| 0 (this device) | K260949 | Disposable Belts for Polysomnography (CNSAC) | CNSAC Medshop GmbH | 2026 | — |
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 |
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 |
|---|---|---|---|
| * | K151361 | Nox RIP Belts & CablesSummary page 5…fort Recorder Accessory Classification Name: Breathing frequency monitor Product Code: MNR Regulation Number: 21 CFR 868.2375 Device Class: Class II Predicate Device (K151361) Primary Predicate: Nox Disposable Inductive Effort Belt Manufacturer: Nox Medical ehf Common Name: Ventilatory Effort Recorder A… | 2015 |
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 35 years and passes through 6 companies; a new generation was cleared every 3.2 years on median.
- 3 of the 30 ancestors have a recall of any class.
- 1 other device also cites its predicate K151361.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 CNSAC Disposable Belts for Polysomnography is intended to measure thoracic and/or abdominal respiratory effort during polysomnography (PSG) sleep studies in adult and pediatric patients greater than 2 years of age. The device is used with compatible polysomnography recording systems in clinical sleep laboratories or similar diagnostic environments. The belt is intended for single-patient use and is worn externally around the thorax or abdomen over clothing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260949 · printed Nov 4, 2026
Cite this page
510(k) Report. “K260949: Disposable Belts for Polysomnography (CNSAC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K260949
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026