510(k) Report

510(k) · Cleared

Recalled · Class II · 2025

Hemochron JR. Microcoagulation Low Range Act

K960749510(k) TraditionalCleared Aug 12, 1996171-day reviewClass II21 CFR 864.7140Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

International Technidyne Corp. · JBP Activated Whole Blood Clotting Time

Cleared on Aug 12, 1996 after a 171-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it. It has been recalled 3 times.

Decided
Aug 12, 1996
Review
171 days
Class
Class II
Product code
JBP
Recalls
3
Predicates
0

3 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2021: 1 descendant cleared2013: 1 descendant cleared2000: 1 descendant cleared1995200020052010201520202025
  1. This deviceK960749 Hemochron JR. Microcoagulation Low Range ActInternational Technidyne Corp. · 1996
  2. Descendant · cites it directly · 1 of its ownK120977 Directcheck Control for Hemochron JR. Microcoagulation Systems…International Technidyne Corp. · 2013
  3. Descendant · cites it directly · 0 of its ownK202101 GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time…Accriva Diagnostics, Inc. · 2021 · Recalled
  4. Descendant · cites it directly · 0 of its ownK992851 Act Test Catridges for Coaguchek Pro System, Act Controls for…Roche Diagnostics Corp. · 2000

Most influential descendants

Showing 3 of 3 · See all
  • K120977Directcheck Control for Hemochron JR. Microcoagulation Systems Act-LR Cuvette…International Technidyne Corp. · 2013 · cites it directly1descendant
  • K202101GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)…Accriva Diagnostics, Inc. · 2021 · cites it directly0descendants
  • K992851Act Test Catridges for Coaguchek Pro System, Act Controls for Coaguchek Pro SystemRoche Diagnostics Corp. · 2000 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K960749Hemochron JR. Microcoagulation Low Range ActInternational Technidyne Corp.1996—
+1K120977Directcheck Control for Hemochron JR. Microcoagulation Systems Act-LR Cuvette…International Technidyne Corp.2013—
+1K202101GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test…Accriva Diagnostics, Inc.20211
+1K992851Act Test Catridges for Coaguchek Pro System, Act Controls for Coaguchek Pro…Roche Diagnostics Corp.2000—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
201310
202110
FIG. 1 — Lineage of K960749, 1996–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K223635 Sonoclot Coagulation & Platelet Function…score 4.6 · 1 generation · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K120977Directcheck Control for Hemochron JR. Microcoagulation Systems Act-LR Cuvette…International Technidyne Corp.20131
K202101GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)…Accriva Diagnostics, Inc.20210
K992851Act Test Catridges for Coaguchek Pro System, Act Controls for Coaguchek Pro SystemRoche Diagnostics Corp.20000

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 5, 2025Class IIZ-0880-2026Packaging process controlTest cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.
May 5, 2009Not classifiedZ-1732-2009Employee errorOne lot of ACT-LR was released when one finished good testing criteria acceptance limit did not meet acceptance criteria.
Apr 27, 2005Not classifiedZ-1381-05OtherValidation had been initiated for a molded component of the finished device but not completed. Also, the device did not meet mean clotting time using Normal Donor Blood as media.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K120977 (International Technidyne Corp., 2013) has gone furthest, with 1 descendant of its own.

How does its category compare?

All JBP devices

JBP Activated Whole Blood Clotting Time: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JBP

1in 2023

2007: 12023: 1
2007high 1 (2007) · low 0 (2008)2026

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

2009: 32010: 32025: 2
2007high 3 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JBP

18in 2025

2007: 52008: 62009: 292010: 242011: 112012: 252013: 322014: 32015: 262016: 42017: 162018: 12019: 152020: 102021: 92022: 72023: 162024: 232025: 18
2007high 32 (2013) · low 1 (2018)2025

MAUDE reports naming product code JBP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—05
20080—06
20090—329
20100—324
20110—011
20120—025
20130—032
20140—03
20150—026
20160—04
20170—016
20180—01
20190—015
20200—010
20210—09
20220—07
20231—016
20240—023
20250—218
20260—0—

More from International Technidyne Corp.

47 FDA decisions under this applicant name. See the company

  • K120977Directcheck Control for Hemochron JR. Microcoagulation Systems Act-LR Cuvette Directcheck Controls for…International Technidyne Corp. · 2013
  • K050016Hemochron Signature EliteInternational Technidyne Corp. · 2005
  • K030818Hemochron Response/SystemInternational Technidyne Corp. · 2003
  • K023561Itc HGB Pro Professional Hemoglobin Testing SystemInternational Technidyne Corp. · 2003
  • K020798Hemochron JR. Signature +International Technidyne Corp. · 2002

Recent decisions in JBP

The JBP category page

  • K223635Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot ViewerSienco, Inc. · 2023
  • K062604Rapidteg Teg-Act TestHaemoscope Corp. · 2007
  • K032952Aiact KitSienco, Inc. · 2003
  • K023582I-Stat Kaolin Act TestI-Stat Corporation · 20032 recalls
  • K020914Actalyke XL Activated Clotting Time Analyzer, Model 5770Helena Laboratories · 2002

https://510kreport.com/device/K960749 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960749: Hemochron JR. Microcoagulation Low Range Act.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960749

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026