510(k) · Cleared
ClearedB&D Activated Clotting Time (Act) Test Tubes BD-C101 (Diatomaceous Earth) and BD-K101 (Kaolin)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B & D Corp. · JBP Activated Whole Blood Clotting Time
Cleared on Oct 1, 1997 as substantially equivalent to K913861 (International Technidyne Corp., 1991) after a 127-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Oct 1, 1997
- Review
- 127 days
- Class
- Class II
- Product code
- JBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913861 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK913861 Hemochron (R) KactInternational Technidyne Corp. · 1991
- This deviceK971935 B&D Activated Clotting Time (Act) Test Tubes BD-C101 (Diatomaceous…B & D Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913861 | Hemochron (R) Kact | International Technidyne Corp. | 1991 | — |
| 0 (this device) | K971935 | B&D Activated Clotting Time (Act) Test Tubes BD-C101 (Diatomaceous Earth) and… | B & D Corp. | 1997 | — |
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? (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 |
|---|---|---|---|
| * | K913861 | Hemochron (R) KactSummary page 1…omaceous earth) and BD-K101(kaolin) Predicate Device International Technidyne Corp. FTCA510 (diatomaceous earth) - a preamendment device, marketed since 1970, and KACT (K913861). Device Description Activated coagulation time (ACT) test tubes are used for monitoring heparin and aprotinin anticoagulation… | 1991 |
| * | — | International Technidyne Corp. FTCA510 (diatomaceous earth) 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)
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.
- 1 other device also cites its predicate K913861.
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?
B&D Activated Clotting Time (ACT) test tubes are intended for use in monitoring anticoagulation effects of heparin. Heparin is commonly used during coronary bypass surgery, coronary angioplasty and several other medical/surgical procedures in order to prevent thrombus formation. B&D Kaolin ACT test tubes (BD-K101) are not sensitive to aprotinin, and are the appropriate ACT test tubes to monitor heparin in patients treated with the moderate levels of…
Read the full statement (115 words)
B&D Activated Clotting Time (ACT) test tubes are intended for use in monitoring anticoagulation effects of heparin. Heparin is commonly used during coronary bypass surgery, coronary angioplasty and several other medical/surgical procedures in order to prevent thrombus formation. B&D Kaolin ACT test tubes (BD-K101) are not sensitive to aprotinin, and are the appropriate ACT test tubes to monitor heparin in patients treated with the moderate levels of protease inhibitor, aprotinin (up to 180 KIU/mL).
B&D ACT test tubes are for whole blood, in-vitro diagnostic use only.
B&D ACT test tubes are to be used with several whole blood ACT analyzers currently available, such as Hemochron® ACT analyzers Model numbers: 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/K971935 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971935: B&D Activated Clotting Time (Act) Test Tubes BD-C101 (Diatomaceous Earth) and BD-K101 (Kaolin).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971935
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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