Neurology · 510(k) · 2026
Onera SleepMap (SLEEPMAP)
Onera B.V.. Cleared by FDA on 8 March 2026 under submission K253668, product code OLZ (automatic event detection software for polysomnograph with electroencephalograph). What FDA's record says, in FDA's words.
Device record · K253668
- Device. Onera SleepMap (SLEEPMAP)DEVICE
- Company. Onera B.V. (NL)COMPANY
- Decision. 8 March 2026, 510(k), substantially equivalent (traditional review); received 21 November 2025DECISION
- Panel. NeurologyPANEL
- Product code. OLZ, Automatic Event Detection Software For Polysomnograph With ElectroencephalographCODE
- Regulation. 21 CFR 882.1400, Class IIREG
- Source. FDA database entry · decision document (16 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. Please provide the device trade name(s). I K253668 Onera SleepMap (SLEEPMAP) [Please provide your Indications for Use below. SleepMap system is intended for use as an aid for physicians in the diagnosis of sleep and respiratory related disorders in adult patients (aged 18 and up), who have been prescribed a sleep study by their doctor. SleepMap is a software- only medical device to be used under the supervision of a clinician to analyze physiological signals and automatically score sleep study recordings, including the staging of sleep, detection of arousals, leg movements, desaturations, obstructive apneas and obstructive hypopneas. Respiratory event subtypes (central and mixed apneas; central hypopneas), RERA, Cheyne Stokes Breathing, Snoring Events, and Arrhythmia Events are not automatically detected and must be manually marked within records. All automatically scored stages and detected events can be manually marked or edited within records during review. All automatically scored stages, detected events and physiological signals which are retrieved, analyzed, displayed, and summarized are subject to verification by a qualified clinician I
The product code's definition, from FDA's classification record. Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All output subject to verification by qualified user
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 10 reports filed against devices carrying product code OLZ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 July 2026 · Other · DREAM BAND/ OXI BAND ENSO SLEEP PPG · report MW6000076
PATIENT STATES THAT THE ACCURACY OF THE DREAM BAND/ OXI BAND ENSO SLEEP PPG IS INACCURATE. THE PATIENT HAD ISSUES SLEEPING, VISITED A DOCTOR, AND WAS PROVIDED THE DREAM BAND. SHE STATES THE DEVICE DOES NOT RECORD THE PROPER DATA THAT CAN DIAGNOSE A SLEEP DISORDER. STATES SHE LOOKED UP THE SCIENTIFIC LITERATURE FOR THE DEVICE AND IT SAYS THE BAND CAN NOT BE USED TO DIAGNOSE A SLEEP DISORDER. PATIENT DOES NOT BELIEVE PHYSICIANS SHOULD PROVIDE THIS DEVICE TO PEOPLE WHO ARE LOOKING FOR SOLUTIONS […]
29 October 2025 · Malfunction · ALICE 6, LDXS HEADBOX · RESPIRONICS, INC. · report 2518422-2025-050129
THE MANUFACTURER RECEIVED INFORMATION FROM CUSTOMER IN REFERENCE TO AN ALICE 6, LDXS HEADBOX WITH AN ALLEGATION OF END RENTAL LOANER. THERE WAS NO REPORT OF SERIOUS INJURY OR HARM. THERE IS NO MEDICAL INTERVENTION WAS SPECIFIED. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTRE. AND OBSERVED THE PCA WITH ELECTRICAL DAMAGE AND ADDITIONAL FAILURES WAS OBSERVED. THE CUSTOMER COMPLAINT WAS NOT REPRODUCED. THERE WAS CHEST STEP ERROR CODE HAS BEEN IDENTIFIED.
11 August 2025 · Malfunction · SLEEPWARE · RESPIRONICS, INC. · report 2518422-2025-108959
THE MANUFACTURER WAS CONTACTED IN REGARDS TO A PATIENT STATING SHE FELT HEAT FROM THE UNIT AND IT MADE A RED BURN MARK ON HER CHEST. THE UNIT PERFORMED/RECORDED THE HSAT TEST AS NORMAL. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
10 January 2025 · Malfunction · ALICE 6 · RESPIRONICS, INC. · report 2518422-2025-100390
THIS REPORT IS BEING SUBMITTED TO INCLUDE THE PRODUCT UDI.
11 July 2024 · Malfunction · SOFTWARE UPGRADE · NATUS MEDICAL INCORPORATED · report 9612330-2024-00035
SOFTWARE UPGRADE: SLEEPWORKS 10 REPORTS DATA IS INCORRECT. SPO2 MEAN VALUE IS LOWER THAN STUDY'S MINIMUM SPO2 VALUE.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code OLZ, in Neurology, or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.