# Advanced Brain Monitoring, Inc.

- Location (FDA's records): Dousman, WI
- FDA decisions: 15 (2004–2018): 15 510(k) clearances
- Names in FDA's records: Advanced Brain Monitoring, Inc. (14); Advanced Brain Monitoring (1)
- Product codes: MNR (6), OLZ (3), OMC (3), MYB (1), LRK (1), GWQ (1)
- Predicates its devices cite: 22 (14 its own); citations of its devices by later devices: 30 (14 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Respironics Inc., Sleep & Home Respiratory Group: 1 (https://510kreport.com/company/respironics-sleep-home-respiratory-group)
- Compumedics Limited: 1 (https://510kreport.com/company/compumedics)
- Sleep Specialists, LLC: 1 (https://510kreport.com/company/sleep-specialists)
- Airway Management, Inc.: 1 (https://510kreport.com/company/airway-management)
- Eb Neuro S.P.A.: 1 (https://510kreport.com/company/eb-neuro)
- Itamar Medical, Ltd.: 1 (https://510kreport.com/company/itamar-medical)
- Younes Sleep Technologies: 1 (https://510kreport.com/company/younes-sleep-technologies)
- Apneicare, LLC: 1 (https://510kreport.com/company/apneicare)

## Firms that cite its devices most
- Zephyr Sleep Technologies: 2 (https://510kreport.com/company/zephyr-sleep-technologies)
- Zeto, Inc.: 2 (https://510kreport.com/company/zeto)
- Cryptych Pty, Ltd.: 1 (https://510kreport.com/company/cryptych)
- Widemed, Ltd.: 1 (https://510kreport.com/company/widemed)
- Ensodata, Inc.: 1 (https://510kreport.com/company/ensodata)
- Neurozone Msh Incorporated: 1 (https://510kreport.com/company/neurozone-msh)
- Bioserenity Sas: 1 (https://510kreport.com/company/bioserenity)
- Nightbalance BV: 1 (https://510kreport.com/company/nightbalance)

## Its most-cited devices
- K131383: X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic Software (2013), cited by 5
- K112514: Apnea Risk Evaluation System (Ares) (2012), cited by 5
- K153412: Sleep Profiler (2016), cited by 4
- K130013: X4 System (2013), cited by 2
- K111194: Apnea Risk Evaluation System (Ares) (2011), cited by 2
- K111110: Apnea Guard (2011), cited by 2

## Recent decisions
- K172799: Positional Sleep Assessment System (PoSAS) software (Mar 9, 2018)
- K153412: Sleep Profiler (Mar 14, 2016)
- K152040: X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29) (Oct 30, 2015)
- K140190: Night Shift (May 29, 2014)
- K131383: X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic Software (Nov 27, 2013)
- K130007: Sleep Profiler (Apr 17, 2013)
- K130013: X4 System (Jan 31, 2013)
- K120450: Sleep Profiler (Sep 19, 2012)

Source page: https://510kreport.com/company/advanced-brain-monitoring