SOMNUM (SOMNUM)

K253390

Honeynaps Co., Ltd. · cleared 2026-06-27 · product code OLZ · Neurology

FDA 510(k) summary for SOMNUM (SOMNUM) (K253390)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
2
Cited predicates
3
Performance observations
4
Product code
OLZ
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.7)
“SOMNUM is an AI-enabled stand-alone software application that analyzes previously recorded physiological data obtained during level 1 sleep studies from adults (polysomnography, PSG records).”
Algorithmartificial intelligence (AI)–based algorithms; AI/ML algorithms
source quote (p.7)
“SOMNUM automatically detects events and displays scoring results using artificial intelligence (AI)–based algorithms across all functional modules. Automated AI algorithms are applied to raw signals to identify specific events. In particular, the Sleep Stage Classification module, the Arousal Detection module, the Respiratory Event Detection module, and the Leg Movement Detection module are all powered by AI/ML algorithms.”
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=100 cases · 4 site(s)

endpoints: Sleep Stage Classification; Arousal Detection; Respiratory Event Detection; Periodic Limb Movement (PLMS) Detection; Sleep Scoring Variables; Apnea-Hypopnea Index (AHI)

standards: AASM Scoring Manual criteria

Retrospective clinical

n=48 cases · 3 site(s)

endpoints: epoch-level agreement; subject-level agreement for sleep variables; patient-level diagnostic performance for sleep apnea

Reported performance (4 observations)

sensitivity100CI 100.0-100.0
source quote (p.20)
“100.0% (100.0-100.0)”
specificity99.29CI 99.23-99.34
source quote (p.18)
“99.29% [99.23-99.34]”
agreement_kappaas written: “Overall Percent Agreement (OPA) for Hypopnea”98.58CI 98.50-98.65
source quote (p.18)
“98.58% [98.50-98.65]”
agreement_kappaas written: “Positive Percent Agreement (PPA) for Arousal”83.8CI 82.62-84.97
source quote (p.17)
“83.8% [82.62-84.97]”

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

Not yet tracked — the weekly postmarket refresh hasn't snapshotted this device.

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.

Related FDA clearances

More AI/ML devices under product code OLZ

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

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DeepRESP

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Dreem 3S

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cleared 2024-11-22

SleepStageML

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cleared 2024-03-08

Dreem 3S

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cleared 2023-08-18

SomnoMetry

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cleared 2022-09-21

EnsoSleep

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cleared 2021-06-16

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K253390