# Natus Medical, Inc.

- Location (FDA's records): San Carlos, CA
- FDA decisions: 23 (1995–2018): 22 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Natus Medical, Inc. (12); Natus Medical Incorporated (11)
- Product codes: LBI (6), GWJ (5), GWQ (2), GWF (2), EWO (2), HKI (1), OMB (1), OMA (1), GHS (1), EWE (1), MXM (1)
- 510(k) review time since 2016: median 113 days, against 134 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 33 (8 its own); citations of its devices by later devices: 37 (8 its own)
- Recalls linked to its devices: 14 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bio-Logic Systems Corp.: 9 (https://510kreport.com/company/bio-logic-systems)
- Otodynamics, Ltd.: 2 (https://510kreport.com/company/otodynamics)
- Medix I.C.S.A.: 2 (https://510kreport.com/company/medix-icsa)
- Olympic Medical Corp.: 2 (https://510kreport.com/company/olympic-medical)
- Intelligent Hearing Systems: 1 (https://510kreport.com/company/intelligent-hearing-systems)
- Clarity Medical Systems: 1 (https://510kreport.com/company/clarity-medical-systems)
- Fischer-Zoth Audiologic Systems, Inc.: 1 (https://510kreport.com/company/fischer-zoth-audiologic-systems)
- Excel Tech., Ltd.: 1 (https://510kreport.com/company/excel-tech)

## Firms that cite its devices most
- Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek): 5 (https://510kreport.com/company/natus-medical-dba-excel-tech-xltek)
- Bio-Logic Systems Corp.: 3 (https://510kreport.com/company/bio-logic-systems)
- Medix I.C.S.A.: 2 (https://510kreport.com/company/medix-icsa)
- Cadwell Industries, Inc.: 2 (https://510kreport.com/company/cadwell-industries)
- Excel-Tech Ltd. (Xltek): 2 (https://510kreport.com/company/excel-tech-xltek)
- Respironics Inc., Sleep & Home Respiratory Group: 2 (https://510kreport.com/company/respironics-sleep-home-respiratory-group)
- Medical Select, Inc.: 1 (https://510kreport.com/company/medical-select)
- Neolight, LLC: 1 (https://510kreport.com/company/neolight)

## Its most-cited devices
- K022196: Natus Blue Light Phototherapy Unit (2002), cited by 8
- K093304: Protektor 32 (2010), cited by 3
- K013137: Algo 3 Newborn Hearing Screener (2001), cited by 3
- K143440: Natus Quantum (2015), cited by 3
- K936039: Algo-2 Newborn Hearing Screener (1995), cited by 3
- K090019: Natus Neuroworks, Model 104196 (2010), cited by 3

## Recent decisions
- K182178: neoBLUE blanket LED Phototherapy System (Dec 13, 2018)
- K182263: RetCam 3 ; RetCam Shuttle ; RetCam Portable (Sep 7, 2018)
- K160745: neoBLUE compact LED Phototherapy System (Dec 12, 2016)
- K160305: neoBLUE® LED Phototherapy System (May 27, 2016)
- K143440: Natus Quantum (Apr 20, 2015)
- K141446: Echo-Screen Iii Pro Hearing Screener with Barcode Scanner, Echo-Screen Iii Pro Hearing Screener Without Barcode Scanner, (Aug 22, 2014)
- K112247: A Baer with Abaer I/O Function (Apr 2, 2012)
- K111618: Audx Otoacoustic Emissions Measurement System with Audx I/O Function (Dec 28, 2011)

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