510(k) · Cleared
Recalled · 2010I-Stat System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I-Stat Corp. · JBP Activated Whole Blood Clotting Time
Cleared on Feb 10, 2000 after a 192-day review. The FDA summary names its predicate without a number. It has been recalled 4 times.
- Decided
- Feb 10, 2000
- Review
- 192 days
- Class
- Class II
- Product code
- JBP
- Recalls
- 4
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | Hemochron® Systems Activated Clotting Time Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 3, 2010 | Not classified | Z-1341-2011 | Device Design | Celite ACT cartridges have increased numbers of values outside the accepted allowable error. |
| Oct 6, 2010 | Not classified | Z-0399-2011 | Other | Certain lots of i-STAT Celite ACT and Kaolin ACT cartridges may be difficult to fill or will not fill when attempting to transfer blood to the sample entry port of the cartridge. |
| Aug 18, 2009 | Not classified | Z-0813-2010 | Labeling False and Misleading | Labeling discrepancy: The manual instruction state that the line should be flushed with 5 mL of saline and the first 5 mL of blood or six dead space volumes should be discarded. The Cartridge Test Information sheets that it should be 2 mL… |
| Mar 16, 2005 | Not classified | Z-0912-05 | Other | Misidentification of Celite ACT cartridge as kaolin ACT Cartridge in the analyzer. |
No ancestor or descendant has a Class I 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.
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 i-STAT Celite ACT test is useful for monitoring patients receiving heparin for
treatment of pulmonary embolism or venous thrombosis, and for monitoring
anticoagulation therapy in patients undergoing medical procedures such as
catheterization, cardiac surgery, surgery, organ transplant and dialysis.
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/K992571 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992571: I-Stat System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992571
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026