510(k) Report

510(k) · Cleared

Cleared

Hepcon HMS with Body Surface Area Calculation

K911240510(k) TraditionalCleared Jul 17, 1991118-day reviewClass II21 CFR 864.5680

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

Hemotech, Inc. · JOX Analyzer, Heparin, Automated

Cleared on Jul 17, 1991 after a 118-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Jul 17, 1991
Review
118 days
Class
Class II
Product code
JOX
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2000: 1 descendant cleared1990200020102020
  1. This deviceK911240 Hepcon HMS with Body Surface Area CalculationHemotech, Inc. · 1991
  2. Descendant · cites it directly · 0 of its ownK993519 Rapidpoint Accent, Model 2000, Rapidpoint Coag Heparin Titration…Cardiovascular Diagnostics, Inc. · 2000

Most influential descendants

Showing 1 of 1 · See all
  • K993519Rapidpoint Accent, Model 2000, Rapidpoint Coag Heparin Titration Test, Rapidpoint Coag…Cardiovascular Diagnostics, Inc. · 2000 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K911240Hepcon HMS with Body Surface Area CalculationHemotech, Inc.1991—
+1K993519Rapidpoint Accent, Model 2000, Rapidpoint Coag Heparin Titration Test…Cardiovascular Diagnostics, Inc.2000—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
FIG. 1 — Lineage of K911240, 1991–2000Source: 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.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K993519Rapidpoint Accent, Model 2000, Rapidpoint Coag Heparin Titration Test, Rapidpoint Coag…Cardiovascular Diagnostics, Inc.20000

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?

  • Of its descendants, K993519 (Cardiovascular Diagnostics, Inc., 2000) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JOX devices

JOX Analyzer, Heparin, Automated: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JOX

1in 2011

2010: 22011: 1
2007high 2 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOX

Too few JOX 510(k)s in any year since 2007 to give a median.

Recalls per year · JOX

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · JOX

65in 2025

2014: 32019: 12022: 292023: 502024: 302025: 65
2007high 65 (2025) · low 0 (2007)2025

MAUDE reports naming product code JOX, 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
20070—00
20080—00
20090—10
20102—00
20111—00
20120—00
20130—00
20140—03
20150—00
20160—00
20170—00
20180—00
20190—01
20200—00
20210—00
20220—029
20230—050
20240—030
20250—065
20260—0—

Recent decisions in JOX

The JOX category page

  • K111339Hemostasis Managment System Plus (HMS-Plus)Medtronic, Inc. · 2011
  • K102953Heparin Dose Response CartridgeMedtronic, Inc. · 2010
  • K101271Hemostasis Management System Plus (HMS Plus ), Model 305 XXMedtronic, Inc. · 2010
  • K051040Heparin Dose Response Controls, Model 306-20 PorMedtronic Perfusion Systems · 2005
  • K043080Heparin Dose Response Controls, Model 306-20 PorMedtronic Vascular · 2004

https://510kreport.com/device/K911240 · printed Nov 5, 2026

Cite this page

510(k) Report. “K911240: Hepcon HMS with Body Surface Area Calculation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K911240

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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