510(k) · Cleared
ClearedReport Studio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beacon Biosignals, Inc. · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Aug 25, 2026 as substantially equivalent to K241288 (Nox Medical Ehf, 2024) after a 90-day review. Its family tree reaches back 11 generations to 1997.
- Decided
- Aug 25, 2026
- Review
- 90 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K962603 (1997). 43 ancestors in all, the oldest K873535 (1987). No later device cites it as a predicate yet.
- Root · 11 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 7 generations between
- 3 generations backK162627 EnsoSleepEnsodata, Inc. · 2017
- 2 generations backK221179 SomnoMetryNeumetry Medical, Inc. · 2022
- 1 generation backK241288 Noxturnal WebNox Medical Ehf · 2024
- This deviceK261747 Report StudioBeacon Biosignals, Inc. · 2026
Show all 11 generations
- Root · 11 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 10 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 9 generations backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- 8 generations backK040595 ALICE 5Respironics, Inc. · 2004 · Recalled
- 7 generations backK112102 Michele Sleep Scoring SystemsYounes Sleep Technologies · 2011
- 6 generations backK120450 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2012
- 5 generations backK130007 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2013
- 4 generations backK153412 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2016
- 3 generations backK162627 EnsoSleepEnsodata, Inc. · 2017
- 2 generations backK221179 SomnoMetryNeumetry Medical, Inc. · 2022
- 1 generation backK241288 Noxturnal WebNox Medical Ehf · 2024
- This deviceK261747 Report StudioBeacon Biosignals, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −10 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −9 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| −8 | K040595 | ALICE 5 | Respironics, Inc. | 2004 | 1 |
| −7 | K112102 | Michele Sleep Scoring Systems | Younes Sleep Technologies | 2011 | — |
| −6 | K120450 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2012 | — |
| −5 | K130007 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2013 | — |
| −4 | K153412 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2016 | — |
| −3 | K162627 | EnsoSleep | Ensodata, Inc. | 2017 | — |
| −2 | K221179 | SomnoMetry | Neumetry Medical, Inc. | 2022 | — |
| −1 | K241288 | Noxturnal Web | Nox Medical Ehf | 2024 | — |
| 0 (this device) | K261747 | Report Studio | Beacon Biosignals, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2020 | 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 OLV? 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 OLV device
- #1 K241288 Noxturnal Webscore 17.3 · 10 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 |
|---|---|---|---|
| * | K241288 | Noxturnal WebSummary page 5…Katrinartuni 2, IS - 105 Reykjavik, Iceland Predicate Device/Trade Name Noxturnal Web Predicate 510(k) K241288 Page 1 of 8 1. DEVICE DESCRIPTI… | 2024 |
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 8 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 43 ancestors have a recall of any class.
- 1 other device also cites its predicate K241288.
How does its category compare?
All OLV devicesOLV Standard Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · OLV
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLV
141in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLV
No recall names OLV since 2007.
Adverse event reports per year · OLV
1in 2025
MAUDE reports naming product code OLV, 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 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 3 | 83 | 0 | 0 |
| 2018 | 3 | 141 | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Report Studio is a web-based software-only medical device indicated for use in diagnostic evaluation by qualified healthcare professionals to assess sleep quality and as an aid for the diagnosis of sleep and respiratory-related disorders. Report Studio supports the display, review, and manual scoring of physiological recordings containing cardiopulmonary, electroencephalographic (EEG), and/or other polysomnographic (PSG) signals. Report Studio supports…
Read the full statement (99 words)
Report Studio is a web-based software-only medical device indicated for use in diagnostic evaluation by qualified healthcare professionals to assess sleep quality and as an aid for the diagnosis of sleep and respiratory-related disorders.
Report Studio supports the display, review, and manual scoring of physiological recordings containing cardiopulmonary, electroencephalographic (EEG), and/or other polysomnographic (PSG) signals. Report Studio supports display and user adjudication of recording metadata and annotations, can report basic statistical information regarding such content, and can aid in the generation of summary reports from user input, but does not itself independently provide automated sleep staging or similar capabilities.
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/K261747 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261747: Report Studio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261747
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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