510(k) · Cleared
ClearedSonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sienco, Inc. · JBP Activated Whole Blood Clotting Time
Cleared on Jan 4, 2023 as substantially equivalent to K002528 (Sienco, Inc., 2000) and 1 other predicate after a 30-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jan 4, 2023
- Review
- 30 days
- Class
- Class II
- Product code
- JBP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K952560 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK952560 Sonoclot Coagulation & Platelet Function AnalyzerSienco, Inc. · 1995
- This deviceK223635 Sonoclot Coagulation & Platelet Function Analyzer System with…Sienco, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952560 | Sonoclot Coagulation & Platelet Function Analyzer | Sienco, Inc. | 1995 | — |
| 0 (this device) | K223635 | Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer | Sienco, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JBP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K002528 | Sonoclot Coagulation & Platelet Function Analyzer System with Signature Viewer OptionSummary page 4…Predicate Trade Name (Primary predicate is listed first) Product Code Sonoclot Coagulation & Platelet Function Analyzer System with Signature K002528 JBP Viewer Option K952560… | 2000 |
| * | K952560 | Sonoclot Coagulation & Platelet Function AnalyzerSummary page 4…atelet Function Analyzer System with Signature K002528 JBP Viewer Option K952560 Sonoclot Coagulation & Platelet Function Analyzer JPA Device Description Summary… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All JBP devicesJBP Activated Whole Blood Clotting Time: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · JBP
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JBP
Too few JBP 510(k)s in any year since 2007 to give a median.
Recalls per year · JBP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JBP
18in 2025
MAUDE reports naming product code JBP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 5 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 0 | — | 3 | 29 |
| 2010 | 0 | — | 3 | 24 |
| 2011 | 0 | — | 0 | 11 |
| 2012 | 0 | — | 0 | 25 |
| 2013 | 0 | — | 0 | 32 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 26 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 10 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 1 | — | 0 | 16 |
| 2024 | 0 | — | 0 | 23 |
| 2025 | 0 | — | 2 | 18 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Sonoclot Coagulation & Platelet Function Analyzer System is an in vitro diagnostic device for measuring coagulation and platelet function. This system has two configurations. The historic configuration is a Sonoclot Analyzer connected to a thermal graphics printer. The standard configuration is a Sonoclot Analyzer connected to a computer running Sonoclot Viewer data collection software. The Sonoclot Analyzer System rapidly provides information on the…
Read the full statement (149 words)
The Sonoclot Coagulation & Platelet Function Analyzer System is an in vitro diagnostic device for measuring coagulation and platelet function. This system has two configurations. The historic configuration is a Sonoclot Analyzer connected to a thermal graphics printer. The standard configuration is a Sonoclot Analyzer connected to a computer running Sonoclot Viewer data collection software.
The Sonoclot Analyzer System rapidly provides information on the entire hemostasis process including coagulation, fibrin gel formation, clot retraction (platelet function) and fibrinolysis.
The Sonoclot Analyzer System generates a qualitative graph, known a the Sonoclot Signature, and quantitative results on the clot formation time (Activated Clotting Time-Onset), the rate of fibrin polymerization (Clot Rate), and clot retraction (Platelet Function). This information can be used to identify numerous coagulopathies including platelet dysfunction, factor deficiencies, anticoagulant effect, hypercoagulable tendencies and hyperfibrinolysis. Different disposable tests are available for use with the Sonoclot Analyzer System for different applications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K223635 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223635: Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223635
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026