DeepRESP

K252330

Nox Medical Ehf · cleared 2025-11-17 · product code OLZ · Neurology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“DeepRESP is a cloud-based software as a medical device (SaMD)”
AlgorithmIts algorithmic framework provides the derivation of sleep staging, including arousals, scoring of respiratory events, and key parameters such as the Apnea-Hypopnea Index (AHI) and Central Apnea-Hypopnea Index (CAHI).
source quote (p.5)
“Its algorithmic framework provides the derivation of sleep staging, including arousals, scoring of respiratory events, and key parameters such as the Apnea-Hypopnea Index (AHI) and Central Apnea-Hypopnea Index (CAHI).”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

n=4,030 patients

endpoints: performance of DeepRESP with regard to scoring sleep recordings with electroencephalography (EEG) (i.e., Type I and II)

standards: IEC 62304:2006/A1:2015, IEC 82304-1:2017, ISO 14971:2019, ANSI/AAMI SW96:2023, FDA guidance General Principles of Software Validation, FDA Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

Retrospective clinical

n=5,771 patients

endpoints: performance of DeepRESP on Type III recordings

standards: IEC 62304:2006/A1:2015, IEC 82304-1:2017, ISO 14971:2019, ANSI/AAMI SW96:2023, FDA guidance General Principles of Software Validation, FDA Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

Reported performance (2 observations)

sensitivity0.877
source quote (p.9)
“AHI ≥ 5 PPA%: 87.7”
specificity0.765
source quote (p.9)
“AHI ≥ 5 NPA%: 76.5”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
2
MAUDE reports in code, 12mo
+20%
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Neurology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K252330