510(k) · Cleared
ClearedBio-Logic Sleepscan Product with Built-in Oximeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Logic Systems Corp. · MNR Ventilatory Effort Recorder
Cleared on Aug 22, 1996 as substantially equivalent to K930790 (Bio-Logic Systems Corp., 1994) and 1 other predicate after an 84-day review. Its family tree reaches back 1 generation to 1994. 45 later devices descend from it.
- Decided
- Aug 22, 1996
- Review
- 84 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K930790 (1994). 2 ancestors in all. 45 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK930790 Addition of Built-in Oxymeter to Sleepscan Prod.Bio-Logic Systems Corp. · 1994
- This deviceK962103 Bio-Logic Sleepscan Product with Built-in OximeterBio-Logic Systems Corp. · 1996
- Descendant · cites it directly · 42 of its ownK012437 Devilbiss Sleep Recorder Model # RM60Sunrise Medical Hhg, Inc. · 2002
- Descendant · 2 generations on · 40 of its ownK040595 ALICE 5Respironics, Inc. · 2004 · Recalled
- Descendant · 3 generations on · 18 of its ownK112102 Michele Sleep Scoring SystemsYounes Sleep Technologies · 2011
- Descendant · 4 generations on · 16 of its ownK120450 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2012
- Descendant · 5 generations on · 14 of its ownK130007 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2013
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K012437Devilbiss Sleep Recorder Model # RM60Sunrise Medical Hhg, Inc. · 2002 · cites it directly42descendants
- K040595ALICE 5Respironics, Inc. · 2004 · 2 generations on40descendants
- K112102Michele Sleep Scoring SystemsYounes Sleep Technologies · 2011 · 3 generations on18descendants
- K120450Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2012 · 4 generations on16descendants
- K130007Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2013 · 5 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930790 | Addition of Built-in Oxymeter to Sleepscan Prod. | Bio-Logic Systems Corp. | 1994 | — |
| 0 (this device) | K962103 | Bio-Logic Sleepscan Product with Built-in Oximeter | Bio-Logic Systems Corp. | 1996 | — |
| +1 | K012437 | Devilbiss Sleep Recorder Model # RM60 | Sunrise Medical Hhg, Inc. | 2002 | — |
| +2 | K040595 | ALICE 5 | Respironics, Inc. | 2004 | 1 |
| +3 | K112102 | Michele Sleep Scoring Systems | Younes Sleep Technologies | 2011 | — |
| +4 | K120450 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2012 | — |
| +5 | K130007 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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? (2)
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 |
|---|---|---|---|
| * | K930790 | Addition of Built-in Oxymeter to Sleepscan Prod.Summary page 1…NAME: Sleep and EEG Recorder CLASSIFICATION NAME: Electroencephalograph (per CFR 882.1400) . ___ Q/QM . PREDICATE DEVICES: Bio-logic Sleepscan with Internal Oximeter (K930790) Bio-logic CEEGRAPH TRAVELER Ambulatory EEG Recorder (K954954) Modification to Bio-logic Sleepscan Section 2 - P… | 1994 |
| * | K954954 | Ceegraph Traveler Ambulatory Eeg RecorderSummary page 1…halograph (per CFR 882.1400) . ___ Q/QM . PREDICATE DEVICES: Bio-logic Sleepscan with Internal Oximeter (K930790) Bio-logic CEEGRAPH TRAVELER Ambulatory EEG Recorder (K954954) Modification to Bio-logic Sleepscan Section 2 - Page 2 Product with Built-In Oximeter DESCRIPTION OF THE DEVICE… | 1996 |
What descends from it? (45)
See all 453 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K012437 (Sunrise Medical Hhg, Inc., 2002) has gone furthest, with 42 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.
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 Bio-logic Sleepscan Product is intended for use when it is necessary for a trained health care professional (for example, a Respiratory or EEG Technologist) to perform a Sleep diagnostic study on a patient with a possible Sleep disorder. This test consists of monitoring and recording various electrical signals from the patient, such as EEG signals from the brain, EOG, respiratory signals from transducers which measure air flow, effort, etc., arm and…
Read the full statement (212 words)
The Bio-logic Sleepscan Product is intended for use when it is necessary for a trained health care professional (for example, a Respiratory or EEG Technologist) to perform a Sleep diagnostic study on a patient with a possible Sleep disorder. This test consists of monitoring and recording various electrical signals from the patient, such as EEG signals from the brain, EOG, respiratory signals from transducers which measure air flow, effort, etc., arm and leg movement, body position while sleeping, pulse rate, and level of oxygen in the blood. Analysis features of the Sleepscan product allow for manipulation and presentation of this data in ways which enhance the physician's ability to reach informed diagnostic decisions quickly and efficiently. Although the addition of an internal oximeter does not, in itself, add to the features or capabilities of the Sleepscan product, it provides a simplification in hardware design which results in faster patient setup with fewer potential errors in setup. This latest modification to the Sleepscan product with Built-In Oximeter does not introduce any changes to the intended use of the product.
Sleepscan with Built-In Oximeter can be used for patients of all ages, although most Sleep disorders occur in adults. The equipment does not provide alarms and cannot be used as an automated apnea monitor.
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/K962103 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962103: Bio-Logic Sleepscan Product with Built-in Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962103
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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