Sienco, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Sienco, Inc.” (first 1995, latest 2023), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 81 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 30 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sienco, Inc. took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 158 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JBP | Activated Whole Blood Clotting Time | 4 | 4 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 1 | 1 |
Review panels
- Hematology (5)
Most recent Sienco, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223635 | Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer | JBP | 2023-01-04 | 30 |
| K032952 | AIACT KIT | JBP | 2003-12-12 | 81 |
| K002528 | SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION | JBP | 2000-08-31 | 15 |
| K984141 | GBACT + KIT | JBP | 1999-05-28 | 191 |
| K952560 | SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER | JPA | 1995-09-05 | 95 |
Recalls
openFDA lists no recalls under a recalling firm named Sienco, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Sienco, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Sienco, Inc.” (first 1995, latest 2023), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sienco, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sienco, Inc. is 81 days.
Which FDA product codes appear under Sienco, Inc.?
The most frequent FDA product codes under this applicant name are JBP (Activated Whole Blood Clotting Time, 4); JPA (System, Multipurpose For In Vitro Coagulation Studies, 1).
Next steps
- See all 5 Sienco, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JBP, Sienco, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.