# Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

- Location (FDA's records): Oakville, CA
- FDA decisions: 13 (2016–2024): 13 510(k) clearances
- Names in FDA's records: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) (12); Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek) (1)
- Product codes: GWQ (4), OLV (2), OMB (2), OMA (1), OMC (1), GWJ (1), GWE (1), HKI (1)
- 510(k) review time since 2016: median 56 days, against 108 for FDA's reviews in the same codes and years (7 of 9 faster)
- Predicates its devices cite: 18 (2 its own); citations of its devices by later devices: 5 (2 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Natus Medical, Inc.: 5 (https://510kreport.com/company/natus-medical)
- Ceribell, Inc.: 2 (https://510kreport.com/company/ceribell)
- Grass-Telefactor Divison: 1 (https://510kreport.com/company/grass-telefactor-divison)
- Natus Neurology Incorporated: 1 (https://510kreport.com/company/natus-neurology)
- Moberg Research, Inc.: 1 (https://510kreport.com/company/moberg-research)
- Excel-Tech Ltd. (Xltek): 1 (https://510kreport.com/company/excel-tech-xltek)
- Nihon Kohden America, Inc.: 1 (https://510kreport.com/company/nihon-kohden-america)
- Excel Tech., Ltd.: 1 (https://510kreport.com/company/excel-tech)

## Firms that cite its devices most
- Cadwell Industries, Inc.: 1 (https://510kreport.com/company/cadwell-industries)
- Hippoclinic: 1 (https://510kreport.com/company/hippoclinic)
- Corscience GmbH & Co. KG: 1 (https://510kreport.com/company/corscience)

## Its most-cited devices
- K180421: Natus NeuroWorks (2018), cited by 1
- K200878: Natus NeuroWorks (2020), cited by 1
- K172711: Comet-PLUS (2017), cited by 1
- K180290: Natus Brain Monitor Amplifier (2018), cited by 1
- K180181: Natus Quantum (2018), cited by 1

## Recent decisions
- K242930: Natus BrainWatch System (Nov 19, 2024)
- K233649: ALGO Pro Newborn Hearing Screener (ALGO Pro) (Mar 8, 2024)
- K203500: RetCam Envision (Apr 13, 2021)
- K200878: Natus NeuroWorks (May 18, 2020)
- K173936: Natus Photic Stimulator (Jun 15, 2018)
- K180290: Natus Brain Monitor Amplifier (Jun 14, 2018)
- K180421: Natus NeuroWorks (Mar 14, 2018)
- K173690: Grass TWin (Mar 9, 2018)

Source page: https://510kreport.com/company/natus-medical-dba-excel-tech-xltek