# Circa Scientific, Inc.

- Location (FDA's records): Englewood, CO
- FDA decisions: 8 (2011–2025): 8 510(k) clearances
- Names in FDA's records: Circa Scientific, Inc. (6); Circa Scientific, LLC (2)
- Product codes: DXF (3), FLL (3), DYB (2)
- 510(k) review time since 2016: median 127 days, against 83 for FDA's reviews in the same codes and years (2 of 6 faster)
- Predicates its devices cite: 10 (3 its own); citations of its devices by later devices: 4 (3 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
- Respiratory Support Products, Inc.: 2 (https://510kreport.com/company/respiratory-support-products)
- Talon Surgical: 1 (https://510kreport.com/company/talon-surgical)
- Fiab Spa: 1 (https://510kreport.com/company/fiab)
- Cross Vascular, Inc.: 1 (https://510kreport.com/company/cross-vascular)
- St. Jude Medical, Cardiac Rhythm Management Divisi: 1 (https://510kreport.com/company/st-jude-medical-cardiac-rhythm-management-divisi)
- Merit Medical Systems, Inc.: 1 (https://510kreport.com/company/merit-medical-systems)

## Firms that cite its devices most
- Fiab Spa: 1 (https://510kreport.com/company/fiab)

## Its most-cited devices
- K241414: CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W,  CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) (2024), cited by 2
- K112376: S-Cath Esophageal Temperature Probe and Temperature Monitoring System (2011), cited by 1
- K200943: Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System (2021), cited by 1

## Recent decisions
- K251007: CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) (May 1, 2025)
- K243954: PeriCross™ Epicardial Access Kit (Apr 24, 2025)
- K243193: Cross Wise™ Multi-Use RF Adapter Cable (Nov 26, 2024)
- K241414: CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W,  CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) (Sep 26, 2024)
- K240004: CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); CardioCurve Steerable Sheath Large Curl, 40cm (CC-1040L ); CardioCurve Steerable Sheath Small Curl, 61cm (CC-1061S); CardioCurve Steerable Sheath Medium Curl, 61cm (CC-1061M ); CardioCurve Steerable Sheath Large Curl, 61cm (CC-1061L); CardioCurve Steerable Sheath Small Curl, 71cm (CC-1071S ); CardioCurve Steerable Sheath Medium Curl, 71cm (CC-1071M ); CardioCurve Steer (Jan 31, 2024)
- K222311: CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System (May 25, 2023)
- K200943: Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System (Dec 17, 2021)
- K112376: S-Cath Esophageal Temperature Probe and Temperature Monitoring System (Aug 31, 2011)

Source page: https://510kreport.com/company/circa-scientific