510(k) · Cleared

Cleared

Heparin Dose Response Cartridge, Model 304-20

K042070510(k) SpecialCleared Oct 1, 200460-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 Vascular · JOX Analyzer, Heparin, Automated

Cleared on Oct 1, 2004 as substantially equivalent to K894317 (Hemotec, Inc., 1989) after a 60-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.

Decided: Oct 1, 2004
Review: 60 days
Class: Class II
Product code: JOX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K894317 (1989). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK894317 Hemotec Hepcon HMS Coagulation System & Access.Hemotec, Inc. · 1989 · Recalled
This deviceK042070 Heparin Dose Response Cartridge, Model 304-20Medtronic Vascular · 2004
Descendant · cites it directly · 0 of its ownK102953 Heparin Dose Response CartridgeMedtronic, Inc. · 2010

Most influential descendants

Showing 1 of 1 · See all

K102953Heparin Dose Response CartridgeMedtronic, Inc. · 2010 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K894317	Hemotec Hepcon HMS Coagulation System & Access.	Hemotec, Inc.	1989	1
0 (this device)	K042070	Heparin Dose Response Cartridge, Model 304-20	Medtronic Vascular	2004	—
+1	K102953	Heparin Dose Response Cartridge	Medtronic, Inc.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0

FIG. 1 — Lineage of K042070, 1989–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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

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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	Applicant	Decided	Recalls
*	K894317	Hemotec Hepcon HMS Coagulation System & Access. Summary page 1 …11 Predicate Devices: Hepcon® HMS Coagulation System and its Associated Cartridges and Controls K894317 Device Description The Heparin Dose Response (HDR) cartridge is an in vitro diagnostic test. The HDR cartridge uses fresh whole…	Hemotec, Inc.	1989	1
*	—	currently marketed HDR cartridge Named without a submission number			—

Also cleared against K894317: 4 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K102953	Heparin Dose Response Cartridge	Medtronic, Inc.	2010	0

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 a recall.
Of its descendants, K102953 (Medtronic, Inc., 2010) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K894317.

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

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

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	0	0
2009	0	—	1	0
2010	2	—	0	0
2011	1	—	0	0
2012	0	—	0	0
2013	0	—	0	0
2014	0	—	0	3
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	0
2018	0	—	0	0
2019	0	—	0	1
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	29
2023	0	—	0	50
2024	0	—	0	30
2025	0	—	0	65
2026	0	—	0	—

What is it indicated for?

The heparin dose response cartridge is intended for determining in vitro individual responses to heparinization using whole blood on the HMS or HMS Plus instruments.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042070 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042070: Heparin Dose Response Cartridge, Model 304-20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042070

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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