# Mauna Kea Technologies

- Location (FDA's records): Paris, FR
- FDA decisions: 19 (2005–2022): 19 510(k) clearances
- Names in FDA's records: Mauna Kea Technologies (18); Mauna Kea Technologies, Inc. (1)
- Product codes: OWN (16), GCJ (2), GWG (1)
- 510(k) review time since 2016: median 84 days, against 84 for FDA's reviews in the same codes and years (3 of 8 faster)
- Predicates its devices cite: 45 (29 its own); citations of its devices by later devices: 35 (29 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
- Pentax Medical Company: 4 (https://510kreport.com/company/pentax-medical)
- Boston Scientific Corp: 3 (https://510kreport.com/company/boston-scientific)
- Daniel & Daniel Consulting: 2 (https://510kreport.com/company/daniel-daniel-consulting)
- Superdimension, Ltd.: 2 (https://510kreport.com/company/superdimension)
- Visionsense, Ltd.: 1 (https://510kreport.com/company/visionsense)
- KARL STORZ Endoscopy-America, Inc.: 1 (https://510kreport.com/company/karl-storz-endoscopy-america)
- Cook Endoscopy: 1 (https://510kreport.com/company/cook-endoscopy)
- Cook Ireland, Ltd.: 1 (https://510kreport.com/company/cook-ireland)

## Firms that cite its devices most
- Daniel & Daniel Consulting: 2 (https://510kreport.com/company/daniel-daniel-consulting)
- VPIX Medical, Inc.: 1 (https://510kreport.com/company/vpix-medical)
- Samantree Medical SA: 1 (https://510kreport.com/company/samantree-medical)
- Carl Zeiss Meditec, AG: 1 (https://510kreport.com/company/carl-zeiss-meditec)
- Wuxi Hisky Medical Technologies Co., Ltd.: 1 (https://510kreport.com/company/wuxi-hisky-medical-technologies)

## Its most-cited devices
- K111047: Cellvizio 100 Series System with Confocal Miniprobes (2011), cited by 5
- K123676: Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes (2013), cited by 4
- K172844: Cellvizio 100 Series System with Confocal Miniprobes (2017), cited by 3
- K150831: Cellvizio 100 Series System with Confocal Miniprobes (2015), cited by 2
- K120208: Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes (2012), cited by 2
- K183640: Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes (2019), cited by 2

## Recent decisions
- K220477: Cellvizio 100 series system with confocal Miniprobes (Apr 11, 2022)
- K212322: Cellvizio I.V.E. system with Confocal Miniprobes (Aug 18, 2021)
- K193416: Cellvizio I.V.E. with Confocal Miniprobes (Feb 28, 2020)
- K191144: Cellvizio 100 Series System with Confocal Miniprobes (Jan 24, 2020)
- K183640: Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes (Feb 22, 2019)
- K180270: Cellvizio 100 Series Systems with Confocal Miniprobes (May 22, 2018)
- K172844: Cellvizio 100 Series System with Confocal Miniprobes (Dec 15, 2017)
- K171345: Cellvizio 100 Series Systems with Confocal Miniprobes (Aug 4, 2017)

Source page: https://510kreport.com/company/mauna-kea-technologies