510(k) · Cleared
ClearedAiact Kit
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 Dec 12, 2003 as substantially equivalent to K952560 (Sienco, Inc., 1995) after an 81-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Dec 12, 2003
- Review
- 81 days
- Class
- Class II
- Product code
- JBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952560 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK952560 Sonoclot Coagulation & Platelet Function AnalyzerSienco, Inc. · 1995
- This deviceK032952 Aiact KitSienco, Inc. · 2003
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) | K032952 | Aiact Kit | Sienco, Inc. | 2003 | — |
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.
Top candidate predicates for a new JBP device
- #1 K223635 Sonoclot Coagulation & Platelet Function…score 4.6 · 1 generation · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K952560 | Sonoclot Coagulation & Platelet Function AnalyzerSummary page 1…Classification: Class II, 21 CFR 864.7174 (3) Identification of predicate device to which substantial equivalence is being claimed: SonACT Kit, included in 510(k) # K952560 (4)and (5) Device Description and Intended Use: The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagul… | 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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K952560.
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.
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 aiACT Kit is an in vitro diagnostic test for use with the Sonoclot Coagulation & Platelet Function Analyzer System. The aiACT test is an activated whole blood clotting time test which uses a blend of celite and clay for contact activation. It may also be used with citrated whole blood. The aiACT Kit is intended only for high dose heparin anticoagulation management (ACT > 400 seconds on Sonoclot Analyzer) as typically encountered during…
Read the full statement (116 words)
The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot Coagulation & Platelet Function Analyzer System. The aiACT test is an activated whole blood clotting time test which uses a blend of celite and clay for contact activation. It may also be used with citrated whole blood.
The aiACT Kit is intended only for high dose heparin anticoagulation management (ACT > 400 seconds on Sonoclot Analyzer) as typically encountered during cardiopulmonary bypass surgery. The aiACT test provides ACT results that are substantially unaffected by aprotinin. When used with the Sonoclot Analyzer System, the aiACT test provides quantitative Onset/ACT and Clot Rate results. Do not use the aiACT test for platelet function assessment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032952 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032952: Aiact Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032952
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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