510(k) · Cleared
ClearedAddition of Built-in Oxymeter to Sleepscan Prod.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Logic Systems Corp. · BZQ Monitor, Breathing Frequency
Cleared on Jan 6, 1994 after a 324-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 46 later devices descend from it.
- Decided
- Jan 6, 1994
- Review
- 324 days
- Class
- Class II
- Product code
- BZQ
- Recalls
- None
- Predicates
- 0
46 later devices descend from it, 1 citing it directly.
- This deviceK930790 Addition of Built-in Oxymeter to Sleepscan Prod.Bio-Logic Systems Corp. · 1994
- Descendant · cites it directly · 45 of its ownK962103 Bio-Logic Sleepscan Product with Built-in OximeterBio-Logic Systems Corp. · 1996
- Descendant · 2 generations on · 42 of its ownK012437 Devilbiss Sleep Recorder Model # RM60Sunrise Medical Hhg, Inc. · 2002
- Descendant · 3 generations on · 40 of its ownK040595 ALICE 5Respironics, Inc. · 2004 · Recalled
- Descendant · 4 generations on · 18 of its ownK112102 Michele Sleep Scoring SystemsYounes Sleep Technologies · 2011
- Descendant · 5 generations on · 16 of its ownK120450 Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2012
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K962103Bio-Logic Sleepscan Product with Built-in OximeterBio-Logic Systems Corp. · 1996 · cites it directly45descendants
- K012437Devilbiss Sleep Recorder Model # RM60Sunrise Medical Hhg, Inc. · 2002 · 2 generations on42descendants
- K040595ALICE 5Respironics, Inc. · 2004 · 3 generations on40descendants
- K112102Michele Sleep Scoring SystemsYounes Sleep Technologies · 2011 · 4 generations on18descendants
- K120450Sleep ProfilerAdvanced Brain Monitoring, Inc. · 2012 · 5 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K930790 | Addition of Built-in Oxymeter to Sleepscan Prod. | Bio-Logic Systems Corp. | 1994 | — |
| +1 | K962103 | Bio-Logic Sleepscan Product with Built-in Oximeter | Bio-Logic Systems Corp. | 1996 | — |
| +2 | K012437 | Devilbiss Sleep Recorder Model # RM60 | Sunrise Medical Hhg, Inc. | 2002 | — |
| +3 | K040595 | ALICE 5 | Respironics, Inc. | 2004 | 1 |
| +4 | K112102 | Michele Sleep Scoring Systems | Younes Sleep Technologies | 2011 | — |
| +5 | K120450 | Sleep Profiler | Advanced Brain Monitoring, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZQ? 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 BZQ device
- #1 K251326 Respiration Rate algorithmscore 20.2 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (46)
See all 461 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K962103 | Bio-Logic Sleepscan Product with Built-in Oximeter | 1996 | 45 |
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?
- Of its descendants, K962103 (Bio-Logic Systems Corp., 1996) has gone furthest, with 45 descendants of its own.
How does its category compare?
All BZQ devicesBZQ Monitor, Breathing Frequency: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZQ
255in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZQ
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZQ
2in 2022
MAUDE reports naming product code BZQ, 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 | 2 | — | 0 | 7 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 121 | 0 | 1 |
| 2010 | 2 | — | 1 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 3 |
| 2013 | 3 | 261 | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 3 | 198 | 0 | 10 |
| 2019 | 1 | — | 0 | 13 |
| 2020 | 2 | — | 0 | 10 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 3 | 198 | 0 | 2 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 7 | 255 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K930790 · printed Nov 6, 2026
Cite this page
510(k) Report. “K930790: Addition of Built-in Oxymeter to Sleepscan Prod..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930790
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026