510(k) · Cleared
ClearedHomeSleepTest (HST, HST REM+)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Somnomedics GmbH · OLV Standard Polysomnograph With Electroencephalograph
Cleared on Dec 8, 2024 as substantially equivalent to K201054 (Somnomedics GmbH, 2020) after a 269-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Dec 8, 2024
- Review
- 269 days
- Class
- Class II
- Product code
- OLV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K962603 (1997). 16 ancestors in all, the oldest K930790 (1994). No later device cites it as a predicate yet.
- Root · 5 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 4 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 3 generations backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- 2 generations backK040595 ALICE 5Respironics, Inc. · 2004 · Recalled
- 1 generation backK201054 SOMNOscreen plusSomnomedics GmbH · 2020
- This deviceK240700 HomeSleepTest (HST, HST REM+)Somnomedics GmbH · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −4 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −3 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| −2 | K040595 | ALICE 5 | Respironics, Inc. | 2004 | 1 |
| −1 | K201054 | SOMNOscreen plus | Somnomedics GmbH | 2020 | — |
| 0 (this device) | K240700 | HomeSleepTest (HST, HST REM+) | Somnomedics GmbH | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 2 | 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 |
|---|---|---|---|
| * | K201054 | SOMNOscreen plusSummary page 5…II Regulation Number & Name: 882.1400 Electroencephalograph Review Panel: Neurology Product Codes: OLV, MNR Predicate Device: SOMNOscreen plus, K201054 Reference Device: Somfit, K231546 Indications for Use: The HomeSleepTest is a non-invasive prescription device for hom… | 2020 |
| † | K231546 | Somfit | 2023 |
| † | K221361 | circul™ pro Ring | 2023 |
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 27 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 16 ancestors has a recall of any class.
- 1 other device also cites its predicate K201054.
How does its category compare?
All OLV devicesOLV Standard Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
The HomeSleepTest is a non-invasive prescription device for home use with patients suspected to have sleep disorders including sleep-related breathing disorders. The HomeSleepTest is a diagnostic aid for the detection of sleep-related breathing disorders, sleep staging (REM, N1, N2, N3, Wake), and snoring level. Using three frontal electrodes and one mastoid electrode, the HomeSleepTest records electrical data. In addition, the device records triaxial…
Read the full statement (225 words)
The HomeSleepTest is a non-invasive prescription device for home use with patients suspected to have sleep disorders including sleep-related breathing disorders.
The HomeSleepTest is a diagnostic aid for the detection of sleep-related breathing disorders, sleep staging (REM, N1, N2, N3, Wake), and snoring level. Using three frontal electrodes and one mastoid electrode, the HomeSleepTest records electrical data. In addition, the device records triaxial accelerometer data, ambient light and acoustic data. With help of the ComfortOxyRing, the device records plethysmographic data, as well as SpO2, heart rate and activity data.
The HomeSleepTest calculates and reports to clinicians EEG/EOG/EMG, sleep stages, SpO2, plethysmography, pulse rate and snoring level. Based on this, the HomeSleepTest indices derived parameters, such as autonomic arousal (based on plethysmogram of ring), oxygen desaturation index and hypnogram-derived indices, such as time in each sleep stage, as well as other sleep-related parameters, to aid in determining sleep quality and quantity.
HomeSleepTest data is not intended to be used as the sole or primary basis for diagnosing any sleep disorders, or sleep-related breathing disorders, prescribing treatment, or determining whether additional diagnostic assessment is warranted. The HomeSleepTest is not intended for use in life-support and monitoring systems. The HomeSleepTest and its accessories are not intended for patients requiring monitoring and intensive care. The HomeSleepTest is a prescription device indicated for adult patients aged 21 years and over.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240700 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240700: HomeSleepTest (HST, HST REM+).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240700
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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