510(k) · Cleared
ClearedMax-Act
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Array Medical, Inc. · JBP Activated Whole Blood Clotting Time
Cleared on Dec 11, 1998 as substantially equivalent to K964609 (Array Medical, Inc., 1997) after a 56-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Dec 11, 1998
- Review
- 56 days
- Class
- Class II
- Product code
- JBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964609 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK964609 Actalyke Activated Clotting Time Test System/Clotting Time…Array Medical, Inc. · 1997
- This deviceK983649 Max-ActArray Medical, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964609 | Actalyke Activated Clotting Time Test System/Clotting Time Tubes/Whole Blood… | Array Medical, Inc. | 1997 | — |
| 0 (this device) | K983649 | Max-Act | Array Medical, Inc. | 1998 | — |
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 |
|---|---|---|---|
| * | K964609 | Actalyke Activated Clotting Time Test System/Clotting Time Tubes/Whole Blood QC…Summary page 1…mon Name: Activated clotting time test Classification Name: Activated whole blood clotting time tests Legally Marketed Device: Array Medical Actalyke C-ACT test tube, K964609. Device Description: The MAX-ACT Activated Clotting Time test tubes utilize a “cocktail” of particulate activators (including c… | 1997 |
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.
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 MAX-ACT Activated Clotting Time test tubes are intended for the measurement of the activated clotting time (ACT) test on Actalyke Models Al, AIP, A2, A2P, and on Hemochron Models 400,401,800,801, and 8000.
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/K983649 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983649: Max-Act.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983649
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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