# Capsule Technologie

- Location (FDA's records): Andover, MA
- FDA decisions: 9 (2001–2021): 9 510(k) clearances
- Names in FDA's records: Capsule Technologie (5); Capsule Technologie Sas (4)
- Product codes: MWI (9)
- 510(k) review time since 2016: median 133 days, against 205 for FDA's reviews in the same codes and years (4 of 5 faster)
- Predicates its devices cite: 11 (7 its own); citations of its devices by later devices: 15 (7 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cas Medical Systems, Inc.: 1 (https://510kreport.com/company/cas-medical-systems)
- Masimo Corporation: 1 (https://510kreport.com/company/masimo)
- Agilent Technologies, Inc.: 1 (https://510kreport.com/company/agilent-technologies)
- Ge Medical Systems Information Technologies: 1 (https://510kreport.com/company/ge-medical-systems-information-technologies)

## Firms that cite its devices most
- Capsule Tech, Inc.: 3 (https://510kreport.com/company/capsule-tech)
- Poise Technology Corporation: 1 (https://510kreport.com/company/poise-technology)
- Siemens Medical Solutions Health Services Corporat: 1 (https://510kreport.com/company/siemens-medical-solutions-health-services-corporat)
- Nihon Kohden Corporation: 1 (https://510kreport.com/company/nihon-kohden)
- Bmc Gesellschaft Fur Medizintechnik Mbh: 1 (https://510kreport.com/company/bmc-gesellschaft-fur-medizintechnik-mbh)
- Nuvon, Inc.: 1 (https://510kreport.com/company/nuvon)

## Its most-cited devices
- K032142: Datacaptor (2003), cited by 5
- K013019: Datacaptor (2001), cited by 3
- K171751: SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module (2017), cited by 2
- K020197: Modification to Datacaptor (2002), cited by 2
- K183638: SmartLinx Vitals Plus Patient Monitoring System (2019), cited by 1
- K200856: SmartLinx Vitals Plus Patient Monitoring System (2020), cited by 1

## Recent decisions
- K210204: Capsule Vitals Plus Patient Monitoring System (Oct 19, 2021)
- K200856: SmartLinx Vitals Plus Patient Monitoring System (Jul 10, 2020)
- K183638: SmartLinx Vitals Plus Patient Monitoring System (Apr 17, 2019)
- K180734: SmartLinx Vitals Plus Patient Monitoring System (Aug 8, 2018)
- K171751: SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module (Oct 24, 2017)
- K151071: SmartLinx Vitals Plus Patient Monitoring System (Sep 17, 2015)
- K032142: Datacaptor (Aug 8, 2003)
- K020197: Modification to Datacaptor (Feb 21, 2002)

Source page: https://510kreport.com/company/capsule-technologie