Dreem 3S

K223539

Beacon Biosignals, Inc. · cleared 2023-08-18 · product code OLZ · Neurology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.4)
“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 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 with recurrent and attention layers
source quote (p.5)
“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.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (3)

Reader study (MRMC)

n=38 patients

endpoints: sleep staging output; confusion matrix; subject-level positive agreement (PA) per sleep stage

standards: IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2014, IEC TR 60601-4-2:2016, IEC 60601-2-26, IEC 60601-1-11:2015, IEC 60601-1-6:2010+A1:2013, IEC 62366-1:2015/Amd1:2020, ISO 10993-1 Fifth Edition 2018, ISO 10993-5 Third Edition 2009, ISO 10993-10 Third Edition 2010

Standalone

sample size not stated

endpoints: EEG data quality; acceptability for manual scoring and sleep staging

Bench

sample size not stated

endpoints: usability; tolerability

Reported performance (1 observation)

sensitivity0.982CI 96.73%, 99.3%
source quote (p.9)
“N3 98.2% (96.73%, 99.3%)”

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
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K242094 (decision 2024-11-22) from Beacon Biosignals, Inc. for a matching device line ("Dreem 3S") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K242094

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/K223539