# Compumedics Limited

- Location (FDA's records): Abbotsford, AU
- FDA decisions: 9 (2000–2025): 9 510(k) clearances
- Product codes: MNR (4), OLV (2), GWQ (2), OLY (1)
- 510(k) review time since 2016: median 30 days, against 165 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 17 (5 its own); citations of its devices by later devices: 15 (5 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
- Compumedics Neuro Science Pty, Ltd.: 2 (https://510kreport.com/company/compumedics-neuro-science)
- Compumedics USA, Ltd.: 2 (https://510kreport.com/company/compumedics-usa)
- Compumedics Ptd, Ltd.: 2 (https://510kreport.com/company/compumedics-ptd)
- Consolidated Research of Richmond, Inc. Dba General Sleep CO: 1 (https://510kreport.com/company/consolidated-research-of-richmond-dba-general-sleep)
- Consolidated Research of Richmond, Inc.: 1 (https://510kreport.com/company/consolidated-research-of-richmond)
- Oxford Instruments, Plc.: 1 (https://510kreport.com/company/oxford-instruments)
- Neuro Scan Labs: 1 (https://510kreport.com/company/neuro-scan-labs)
- Itamar Medical, Ltd.: 1 (https://510kreport.com/company/itamar-medical)

## Firms that cite its devices most
- Cleveland Medical Devices, Inc.: 2 (https://510kreport.com/company/cleveland-medical-devices)
- Advanced Brain Monitoring, Inc.: 1 (https://510kreport.com/company/advanced-brain-monitoring)
- Compumedics USA, Ltd.: 1 (https://510kreport.com/company/compumedics-usa)
- Respironics, Inc.: 1 (https://510kreport.com/company/respironics)
- Nox Medical Ehf: 1 (https://510kreport.com/company/nox-medical)
- Nihon Kohden America, Inc.: 1 (https://510kreport.com/company/nihon-kohden-america)
- Somnomedics GmbH: 1 (https://510kreport.com/company/somnomedics)
- Carefusion 209, Inc.: 1 (https://510kreport.com/company/carefusion-209)

## Its most-cited devices
- K003175: Compumedics Siesta System (2000), cited by 6
- K021176: Compumedics Somte System (2003), cited by 4
- K072201: Compumedics Somte PSG Recording System (2008), cited by 3
- K093223: Compumedics Grael System, Models: Grael, Grael Ecg (2010), cited by 1
- K231546: Somfit (2023), cited by 1

## Recent decisions
- K252383: Somfit D (Aug 28, 2025)
- K242447: Falcon HST (Feb 20, 2025)
- K231546: Somfit (Nov 30, 2023)
- K230073: Okti (Feb 9, 2023)
- K191785: Orion LifeSpan MEG (Feb 14, 2020)
- K093223: Compumedics Grael System, Models: Grael, Grael Ecg (Jan 15, 2010)
- K072201: Compumedics Somte PSG Recording System (Apr 14, 2008)
- K021176: Compumedics Somte System (Jan 21, 2003)

Source page: https://510kreport.com/company/compumedics