# Maquet GmbH

- Location (FDA's records): Rastatt, DE
- FDA decisions: 8 (2004–2022): 8 510(k) clearances
- Names in FDA's records: Maquet GmbH (3); Maquet S.A.S. (2); Maquet, Inc. (1); Maquet S.A. (1); Maquet GmbH and Co. KG (1)
- Product codes: FLE (3), CAH (1), NTN (1), FSY (1), BTA (1), FTD (1)
- 510(k) review time since 2016: median 196 days, against 146 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 12 (5 its own); citations of its devices by later devices: 13 (5 its own)
- Recalls linked to its devices: 22 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Heraeus Med GmbH: 2 (https://510kreport.com/company/heraeus-med)
- Siemens Elema AB: 1 (https://510kreport.com/company/siemens-elema)
- Fisher & Paykel Healthcare, Ltd.: 1 (https://510kreport.com/company/fisher-paykel-healthcare)
- Alm S.A.: 1 (https://510kreport.com/company/alm)
- Nouvag AG: 1 (https://510kreport.com/company/nouvag)
- Getinge Sourcing, LLC: 1 (https://510kreport.com/company/getinge-sourcing)

## Firms that cite its devices most
- Medical Illumination International, Inc.: 2 (https://510kreport.com/company/medical-illumination-international)
- Dr. Mach GmbH & Co. KG: 1 (https://510kreport.com/company/dr-mach)
- Maquet Critical Care AB: 1 (https://510kreport.com/company/maquet-critical-care)
- Maquet GmbH (A Getinge Group Company): 1 (https://510kreport.com/company/maquet-a-getinge-group)
- Umbel Corporation: 1 (https://510kreport.com/company/umbel)
- STERIS Corporation: 1 (https://510kreport.com/company/steris)
- Oricare, Inc.: 1 (https://510kreport.com/company/oricare)

## Its most-cited devices
- K070442: Powerled Surgical Light System (2007), cited by 7
- K113679: Lucea Led Surgical Light System (2012), cited by 2
- K172159: Getinge GSS67N Series Steam Sterilizer (2018), cited by 2
- K030071: Servo Guard, Model 64 81 290 EH88E (2004), cited by 1
- K201927: Getinge GSS610N Series Steam Sterilizer (2021), cited by 1

## Recent decisions
- K214120: GSS610N21 Series Steam Sterilizer (May 18, 2022)
- K201927: Getinge GSS610N Series Steam Sterilizer (Mar 1, 2021)
- K172159: Getinge GSS67N Series Steam Sterilizer (Jan 30, 2018)
- K130513: Volista 400; Volista 600 (May 8, 2013)
- K113679: Lucea Led Surgical Light System (Jan 12, 2012)
- K092903: Bora UP 2080, Bora UP 2080 OP and Bora UP 2080 Mounting (Dec 1, 2009)
- K070442: Powerled Surgical Light System (Mar 16, 2007)
- K030071: Servo Guard, Model 64 81 290 EH88E (Apr 26, 2004)

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