510(k) · Cleared
ClearedWRAP System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huneo, LLC · MNR Ventilatory Effort Recorder
Cleared on Jul 15, 2026 as substantially equivalent to K210593 (Onera B.V., 2022) and 2 other predicates after a 189-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- Jul 15, 2026
- Review
- 189 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K962603 (1997). 58 ancestors in all, the oldest K873535 (1987). No later device cites it as a predicate yet.
- Root · 8 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 7 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 6 generations backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- 5 generations backK040595 ALICE 5Respironics, Inc. · 2004 · Recalled
- 4 generations backK112102 Michele Sleep Scoring SystemsYounes Sleep Technologies · 2011
- 3 generations backK120450 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2012
- 2 generations backK130007 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2013
- 1 generation backK153412 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2016
- This deviceK260050 WRAP SystemHuneo, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −7 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −6 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| −5 | K040595 | ALICE 5 | Respironics, Inc. | 2004 | 1 |
| −4 | K112102 | Michele Sleep Scoring Systems | Younes Sleep Technologies | 2011 | — |
| −3 | K120450 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2012 | — |
| −2 | K130007 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2013 | — |
| −1 | K153412 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2016 | — |
| 0 (this device) | K260050 | WRAP System | Huneo, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 6 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K210593 | Onera Sleep Test System (Onera STS)Summary page 5…Regulatory Class: 2 Product Code: MNR, OLV, OLZ Predicate Device(s): 510(k) Number Device Name Type K210593 Onera Sleep Test System (STS) Predicate Device K934599 (IL-PSG) Sandman… | 2022 |
| * | K934599 | SandmanSummary page 5…e(s): 510(k) Number Device Name Type K210593 Onera Sleep Test System (STS) Predicate Device K934599 (IL-PSG) Sandman Predicate Device K153412 Sleep Profiler… | 1994 |
| * | K153412 | Sleep ProfilerSummary page 5…K210593 Onera Sleep Test System (STS) Predicate Device K934599 (IL-PSG) Sandman Predicate Device K153412 Sleep Profiler Predicate Device Device Description: The Wireless Realtime Attended Polysomnog… | 2016 |
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 29 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 4 of the 58 ancestors have a recall of any class.
- 1 other device also cites its predicate K210593.
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 Wireless Realtime Attended Polysomnogram (WRAP) System measures and records multiple physiological parameters from a patient during a sleep study and its autoscoring algorithm scores sleep stages automatically. These recorded physiological parameters are used by clinicians to assist in evaluating the diagnosis of sleep disorders. The WRAP System is intended to be used on a patient, who has been prescribed a sleep study by a healthcare professional.…
Read the full statement (118 words)
The Wireless Realtime Attended Polysomnogram (WRAP) System measures and records multiple physiological parameters from a patient during a sleep study and its autoscoring algorithm scores sleep stages automatically. These recorded physiological parameters are used by clinicians to assist in evaluating the diagnosis of sleep disorders. The WRAP System is intended to be used on a patient, who has been prescribed a sleep study by a healthcare professional. The device is designed to be used under the direction of a physician or trained technician but may be applied by a layperson. The recorded data will be made available to a healthcare professional to assist in the diagnosis of sleep disorders. The device is intended to be used for adults.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260050 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260050: WRAP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260050
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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