510(k) · Cleared
ClearedSandman
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Melville Software, Ltd. · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Jan 27, 1994 after a 125-day review. The FDA summary names no predicate by number. 45 later devices descend from it.
- Decided
- Jan 27, 1994
- Review
- 125 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 0
45 later devices descend from it, 4 citing it directly.
- This deviceK934599 SandmanMelville Software, Ltd. · 1994
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K934599 | Sandman | Melville Software, Ltd. | 1994 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 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 | 2 | 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 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?
The FDA summary names no predicate by number.
What descends from it? (45)
See all 454 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?
- Of its descendants, K012437 (Sunrise Medical Hhg, Inc., 2002) has gone furthest, with 42 descendants of its own.
How does its category compare?
All OLV devicesOLV Standard Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The SANDMAN device is used solely for the collection, storage and display of data either:
a) collected by SANDMAN from FDA approved equipment that requires no modification to support this function, or b) input by the qualified technologist.
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/K934599 · printed Nov 4, 2026
Cite this page
510(k) Report. “K934599: Sandman.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K934599
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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