# Aspect Medical Systems, Inc.

- Location (FDA's records): Newton, MA
- FDA decisions: 25 (1992–2009): 25 510(k) clearances
- Product codes: OLW (12), GXY (9), OLT (2), DRX (1), GWY (1)
- Predicates its devices cite: 29 (27 its own); citations of its devices by later devices: 63 (27 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- General Electric Medical Systems Information Techn: 1 (https://510kreport.com/company/general-electric-medical-systems-information-techn)
- Ndm Corp.: 1 (https://510kreport.com/company/ndm)

## Firms that cite its devices most
- Philips Medizin Systeme Boeblingen GmbH: 6 (https://510kreport.com/company/philips-medizin-systeme-boeblingen)
- Covidien: 4 (https://510kreport.com/company/covidien)
- Datex-Ohmeda, Inc.: 4 (https://510kreport.com/company/datex-ohmeda)
- General Electric Medical Systems Information Techn: 3 (https://510kreport.com/company/general-electric-medical-systems-information-techn)
- Incereb, Ltd.: 2 (https://510kreport.com/company/incereb)
- Nicolet Biomedical, Inc.: 1 (https://510kreport.com/company/nicolet-biomedical)
- Mt Monitortechnik GmbH & Co. KG: 1 (https://510kreport.com/company/mt-monitortechnik)
- Guangdong Biolight Meditech Co., Ltd.: 1 (https://510kreport.com/company/guangdong-biolight-meditech)

## Its most-cited devices
- K040183: BISX (2004), cited by 10
- K002734: Aspect Medical Sytems Eeg Enhanced Bis Sensor 186-0106 (2000), cited by 6
- K974496: A-2000 Eeg Monitor with Bis (1998), cited by 6
- K963644: A-1000 Eeg Monitor and a-1050 Eeg Monitor (1996), cited by 5
- K072286: Bis Eeg Vista Monitor System and Bisx (2007), cited by 5
- K030267: Eeg Monitor with Bis, Model a-2000 (2004), cited by 4

## Recent decisions
- K093183: Bis Quatro Sensor (Oct 23, 2009)
- K091854: Bis Click Sensor/Cable (Jul 2, 2009)
- K072286: Bis Eeg Vista Monitor System and Bisx (Nov 20, 2007)
- K062613: Bis Eeg Monitor View (Jun 18, 2007)
- K070069: Zipprep Electrode (Feb 5, 2007)
- K062692: Bis Bilateral Sensor (Dec 13, 2006)
- K052981: Bis Eeg Monitor, Model BISX4 (Nov 1, 2005)
- K052362: Bis Eeg Monitor, Model a-3000 (Sep 9, 2005)

Source page: https://510kreport.com/company/aspect-medical-systems