510(k) Report

FDA applicant

Circa Scientific, Inc.

Englewood, CO8 decisions2011–20250 recalls

FDA records 8 decisions for Circa Scientific, Inc. (Englewood, CO) from 2011 to 2025: 8 510(k) clearances. Most are in product codes DXF (Catheter, Septostomy) and FLL (Continuous Measurement Thermometer). Since 2016 its 510(k)s took a median of 127 days from receipt to decision, against 83 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Circa Scientific, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Circa Scientific, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2011: 12021: 12023: 12024: 32025: 2
2011high 3 (2024) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Circa Scientific, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Circa Scientific, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DXFCatheter, Septostomy3decisions
  • FLLContinuous Measurement Thermometer3decisions
  • DYBIntroducer, Catheter2decisions

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 127 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 83 days; 2 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K241414CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF…Circa Scientific, Inc. · 20242cite it
  • K112376S-Cath Esophageal Temperature Probe and Temperature Monitoring SystemCirca Scientific, LLC · 20111cites it
  • K200943Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring SystemCirca Scientific, LLC · 20211cites it

What has FDA decided for it lately?

  • K251007CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V…Circa Scientific, Inc. · 2025
  • K243954PeriCross™ Epicardial Access KitCirca Scientific, Inc. · 2025
  • K243193Cross Wise™ Multi-Use RF Adapter CableCirca Scientific, Inc. · 2024
  • K241414CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF…Circa Scientific, Inc. · 2024
  • K240004CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm…Circa Scientific, Inc. · 2024
  • K222311CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring SystemCirca Scientific, Inc. · 2023
  • K200943Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring SystemCirca Scientific, LLC · 2021
  • K112376S-Cath Esophageal Temperature Probe and Temperature Monitoring SystemCirca Scientific, LLC · 2011

All 6 as Circa Scientific, Inc. →All 2 as Circa Scientific, LLC →