Circa Scientific, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Circa Scientific, Inc.” (first 2023, latest 2025), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 90 days. Since 2017 the median was 90 days, against 150 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 1 | 297 |
| 2024 | 3 | 57 |
| 2025 | 2 | 76 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Circa Scientific, Inc. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 150 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXF | Catheter, Septostomy | 3 | 3 |
| DYB | Introducer, Catheter | 2 | 2 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
Review panels
- Cardiovascular (5)
- General Hospital (1)
Most recent Circa Scientific, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251007 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) | DXF | 2025-05-01 | 30 |
| K243954 | PeriCross Epicardial Access Kit | DYB | 2025-04-24 | 122 |
| K243193 | Cross Wise Multi-Use RF Adapter Cable | DXF | 2024-11-26 | 57 |
| K241414 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) | DXF | 2024-09-26 | 132 |
| 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 | DYB | 2024-01-31 | 29 |
| K222311 | CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System | FLL | 2023-05-25 | 297 |
Recalls
openFDA lists no recalls under a recalling firm named Circa Scientific, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Circa Scientific, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06388629: Epicardial Access Study With Rook (Recruiting, started 2023-12-17)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Circa Scientific, LLC (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Circa Scientific, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Circa Scientific, Inc.” (first 2023, latest 2025), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Circa Scientific, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Circa Scientific, Inc. is 90 days. Since 2017: 90 days, versus 150 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Circa Scientific, Inc.?
The most frequent FDA product codes under this applicant name are DXF (Catheter, Septostomy, 3); DYB (Introducer, Catheter, 2); FLL (Continuous Measurement Thermometer, 1).
Next steps
- See all 6 Circa Scientific, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXF, Circa Scientific, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.