Dreem 3S

K242094

Beacon Biosignals, Inc. · cleared 2024-11-22 · product code OLZ · Neurology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The Dreem 3S headband contains microelectronics, within a flexible case made of plastic, foam, and fabric. It includes 6 EEG electrodes and a 3D accelerometer sensor. ... The raw EEG and accelerometer data are transferred to Dreem's servers for further analysis after the night is over. ... The algorithm uses raw EEG data and accelerometer data to provide automatic sleep staging according to the AASM classification. The algorithm is implemented with an artificial neural network.”
Algorithmartificial neural network
source quote (p.6)
“The algorithm uses raw EEG data and accelerometer data to provide automatic sleep staging according to the AASM classification. The algorithm is implemented with an artificial neural network. Frequency spectrums are computed from raw data and then passed to several neural network layers including recurrent layers and attention layers. The algorithm outputs prediction for several epochs of 30 seconds at the same time, every 30 seconds. The various outputs for a single epoch of 30 seconds are combined to provide robust sleep scoring.”
Adaptive (vs locked)Yes
source quote (p.8)
“Dreem 3S includes an authorized Predetermined Change Control Plan (PCCP) that allows for planned updates of the machine learning software device function (ML-DSF) and non-ML algorithmic components to improve sleep staging performance within the existing intended use and indications for use.”
PCCPYes
source quote (p.1)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP).”
Cybersecurity addressedFDA source did not state this

Validation studies (0)

FDA source did not describe a validation study.

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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/K242094