Anesthesiology · 510(k) · 2024
Aurora
EnsoData. Cleared by FDA on 9 February 2024 under submission K231355, product code MNR (ventilatory effort recorder). What FDA's record says, in FDA's words.
Device record · K231355
- Device. AuroraDEVICE
- Company. EnsoDataCOMPANY
- Decision. 9 February 2024, 510(k), substantially equivalent (traditional review); received 10 May 2023DECISION
- Panel. AnesthesiologyPANEL
- Product code. MNR, Ventilatory Effort RecorderCODE
- Regulation. 21 CFR 868.2375, Class IIREG
- Source. FDA database entry · decision document (11 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.
Aurora is a Software as a Medical Device (SaMD) that establishes sleep quality. Aurora automatically analyzes, displays, and summarizes Photoplethysmogram (PPG) data collected during sleep using compatible devices. Aurora is intended for use by and by order of a healthcare professional to aid in the diagnosis of sleep disorders including sleep apnea in adults The Aurora output, including automatically detected respiratory events and parameters, may be displayed and edited by a qualified healthcare professional. The Aurora output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional. Aurora is not intended for use with polysomnography devices.
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 126 reports filed against devices carrying product code MNR. 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:
29 September 2026 · Malfunction · Alice NightOne · Respironics, Inc. · report 50927394
Home sleep testing device did not properly record. Manufacturer response for home sleep test device, Philips Respironics Alice NightOne home sleep test (per site reporter).
29 September 2026 · Malfunction · Alice NightOne · Respironics, Inc. · report 50927402
Home sleep testing recorded did not record properly. Equipment malfunctioned and patient will need to repeat the sleep test. Manufacturer response for home sleep testing device, Alice NightOne home sleep testing device (per site reporter).
21 September 2026 · Injury · WatchPAT ONE · ITAMAR MEDICAL · report MW6002563
I was prescribed the WatchPat One at home sleep test to test for sleep apnea. I followed the instructions for setting up the device and started the test. Seven hours later I woke up to a stinging/buzzing pain on the top of my finger that had the pulse oximeter connected. I moved the pulse ox to a different finger. I noticed two areas ofpain on my finger, and went back to bed. The next morning I woke up to two painful and red spots, one directly below my cuticle and the other about an inch […]
11 September 2026 · Injury · WatchPAT 300 · ITAMAR MEDICAL · report MW6002208
On (b)(6) 2026, I used a (b)(6)-issued WatchPAT home sleep-apnea testing devicefor the first time. Following the (b)(6) instructions, I placed the finger probe on my leftring finger at approximately 10:30 p.m. I woke at approximately 3:36 a.m. because thering finger wearing the WatchPAT probe was completely numb and felt as though itscirculation had been restricted for a prolonged period. I immediately removed thedevice. My thumb and an adjacent finger were also mildly numb, although the […]
8 September 2026 · Other · WatchPAT One · report MW6001962
The patient reported applying the WatchPAT at approximately 10:00 PM on (b)(6) 2026. She stated that she awoke around midnight with intense pain in her left index finger, where the finger probe was being worn. She described the finger as feeling inflamed, with a sensation similar to being "stabbed with a hot needle" near the base of the fingernail. The patient reported attempting to return to sleep for approximately 50 minutes before removing the device. She stated that her finger was red and […]
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 MNR, in Anesthesiology, or cleared in 2024. 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.