510(k) · Cleared
ClearedSomnitor 32K Sleep Activity Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurim Pharmaceuticals, Ltd. · LEL Device, Sleep Assessment
Cleared on Jul 10, 1997 as substantially equivalent to K854030 (Ambulatory Monitoring, Inc., 1986) after a 203-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Jul 10, 1997
- Review
- 203 days
- Class
- Class II
- Product code
- LEL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K854030 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK854030 Wrist ActigraphAmbulatory Monitoring, Inc. · 1986
- This deviceK965079 Somnitor 32K Sleep Activity MonitorNeurim Pharmaceuticals, Ltd. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K854030 | Wrist Actigraph | Ambulatory Monitoring, Inc. | 1986 | — |
| 0 (this device) | K965079 | Somnitor 32K Sleep Activity Monitor | Neurim Pharmaceuticals, Ltd. | 1997 | — |
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 LEL? 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 LEL device
- #1 K252981 EmbraceMiniscore 23.3 · 40 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 |
|---|---|---|---|
| * | K854030 | Wrist ActigraphSummary page 1…r 32K Sleep Activity Monitor is similar in design, intended use, and performance to the Mini-Motion Logger Actigraph by Ambulatory Monitoring which was cleared by FDA as K854030. This 510(k) Summary will summarize the basis for a decision that the Somnitor 32K is substantially equivalent to the predicate d… | 1986 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K854030.
How does its category compare?
All LEL devicesLEL Device, Sleep Assessment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LEL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LEL
96in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LEL
No recall names LEL since 2007.
Adverse event reports per year · LEL
1in 2021
MAUDE reports naming product code LEL, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 3 | 96 | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Somnitor 32K Activity Monitor is intended to monitor physical activity with
an ambulatory device and after downloading the data to a personal computer,
determine the periods when the patient was awake or sleeping using a validated
algorithm.
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/K965079 · printed Nov 5, 2026
Cite this page
510(k) Report. “K965079: Somnitor 32K Sleep Activity Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K965079
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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