510(k) · Cleared
ClearedDeepRESP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nox Medical Ehf · OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Cleared on Nov 17, 2025 as substantially equivalent to K241960 (Nox Medical Ehf, 2025) and 1 other predicate after a 115-day review. Its family tree reaches back 8 generations to 1987.
- Decided
- Nov 17, 2025
- Review
- 115 days
- Class
- Class II
- Product code
- OLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K873535 (1987). 24 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK873535 Nicolet Expert Sleep/Wake Analysis SystemNicolet Biomedical Instruments · 1987
- 7 generations backK955841 Sleep System for Clinics & ResearchCompumedics Ptd, Ltd. · 1997
- 6 generations backK022506 Morpheus 1, Automated Sleep Study Scoring & Data Management SystemWidemed, Ltd. · 2003
- 5 generations backK083620 Somnolyzer 24X7The Siesta Group North America · 2009
- 4 generations backK131994 Somnolyzer 24X7Respironics, Inc. · 2013
- 3 generations backK142988 Sleepware G3Respironics, Inc. · 2015
- 2 generations backK202142 Sleepware G3Respironics, Inc. · 2020
- 1 generation backK241960 DeepRESPNox Medical Ehf · 2025
- This deviceK252330 DeepRESPNox Medical Ehf · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K873535 | Nicolet Expert Sleep/Wake Analysis System | Nicolet Biomedical Instruments | 1987 | — |
| −7 | K955841 | Sleep System for Clinics & Research | Compumedics Ptd, Ltd. | 1997 | — |
| −6 | K022506 | Morpheus 1, Automated Sleep Study Scoring & Data Management System | Widemed, Ltd. | 2003 | — |
| −5 | K083620 | Somnolyzer 24X7 | The Siesta Group North America | 2009 | — |
| −4 | K131994 | Somnolyzer 24X7 | Respironics, Inc. | 2013 | — |
| −3 | K142988 | Sleepware G3 | Respironics, Inc. | 2015 | — |
| −2 | K202142 | Sleepware G3 | Respironics, Inc. | 2020 | — |
| −1 | K241960 | DeepRESP | Nox Medical Ehf | 2025 | — |
| 0 (this device) | K252330 | DeepRESP | Nox Medical Ehf | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2019 | 1 | 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 OLZ? 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 OLZ device
- #1 K253390 Somnum (Somnum)score 14.3 · 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? (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 |
|---|---|---|---|
| * | K241960 | DeepRESPSummary page 5…Additional Predicate Device Name / Manufacturer Number Predicate Predicate K241960 DeepRESP / Nox Medical x K192469 Nox Sleep System / Nox Medical… | 2025 |
| * | K192469 | Nox Sleep SystemSummary page 5…Predicate Predicate K241960 DeepRESP / Nox Medical x K192469 Nox Sleep System / Nox Medical x DEVICE DESCRIPTION DeepRESP is a clou… | 2019 |
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 38 years and passes through 6 companies; a new generation was cleared every 5.6 years on median.
- 2 of the 24 ancestors have a recall of any class.
How does its category compare?
All OLZ devicesOLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OLZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLZ
185in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLZ
No recall names OLZ since 2007.
Adverse event reports per year · OLZ
3in 2025
MAUDE reports naming product code OLZ, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 3 | 122 | 0 | 1 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 4 | 185 | 0 | 3 |
| 2026 | 3 | 155 | 0 | — |
What is it indicated for?
DeepRESP is an aid in the diagnosis of various sleep disorders where subjects are often evaluated during the initiation or follow-up of treatment of various sleep disorders. The recordings to be analyzed by DeepRESP can be performed in a hospital, a patient’s home, or an ambulatory setting. It is indicated for use with adults (18 years and above) in a clinical environment by or on the order of a medical professional. DeepRESP is intended to mark sleep…
Read the full statement (131 words)
DeepRESP is an aid in the diagnosis of various sleep disorders where subjects are often evaluated during the initiation or follow-up of treatment of various sleep disorders. The recordings to be analyzed by DeepRESP can be performed in a hospital, a patient’s home, or an ambulatory setting. It is indicated for use with adults (18 years and above) in a clinical environment by or on the order of a medical professional.
DeepRESP is intended to mark sleep study signals to aid in the identification of events and annotations of traces; automatically calculate measures obtained from recorded signals (e.g., magnitude, time, frequency, and statistical measures of marked events); and infer sleep staging with arousals with EEG and in the absence of EEG. All output is subject to verification by a medical professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252330 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252330: DeepRESP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252330
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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