510(k) Report

510(k) · Cleared

Cleared

HMS Purple and Black Heparin Cartridges & Control

K922031510(k) TraditionalCleared Jul 21, 199281-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

Medtronic Hemotec, Inc. · JOX Analyzer, Heparin, Automated

Cleared on Jul 21, 1992 after an 81-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Jul 21, 1992
Review
81 days
Class
Class II
Product code
JOX
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2010: 1 descendant cleared1990200020102020
  1. This deviceK922031 HMS Purple and Black Heparin Cartridges & ControlMedtronic Hemotec, Inc. · 1992
  2. Descendant · cites it directly · 1 of its ownK042206 Purple/Black Heparin Assay ControlMedtronic Vascular · 2004
  3. Descendant · 2 generations on · 0 of its ownK103313 Heparin Assay ControlsMedtronic, Inc. · 2010

Most influential descendants

Showing 2 of 2 · See all
  • K042206Purple/Black Heparin Assay ControlMedtronic Vascular · 2004 · cites it directly1descendant
  • K103313Heparin Assay ControlsMedtronic, Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K922031HMS Purple and Black Heparin Cartridges & ControlMedtronic Hemotec, Inc.1992—
+1K042206Purple/Black Heparin Assay ControlMedtronic Vascular2004—
+2K103313Heparin Assay ControlsMedtronic, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
201010
FIG. 1 — Lineage of K922031, 1992–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 JOX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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? (2)

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

NumberDeviceApplicantDecidedDescendants
K042206Purple/Black Heparin Assay ControlMedtronic Vascular20041

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, K042206 (Medtronic Vascular, 2004) has gone furthest, with 1 descendant 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—

More from Medtronic Hemotec, Inc.

5 FDA decisions under this applicant name. See the company

  • K954202Platelet Function Test Assay Cartridges for the Hepcon HMSMedtronic Hemotec, Inc. · 1996
  • K944115Heparin Assay Cartridges and ControlsMedtronic Hemotec, Inc. · 1995
  • K940426Medtronic Hemotec Act II Automated Coagulation TimerMedtronic Hemotec, Inc. · 1994
  • K923594Clottrac Coagulation ControlMedtronic Hemotec, Inc. · 1992

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/K922031 · printed Nov 6, 2026

Cite this page

510(k) Report. “K922031: HMS Purple and Black Heparin Cartridges & Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922031

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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