510(k) · Cleared

Cleared

Clotrac Heparinase Test Cartidge (HTC) Coagulation Control

K103314510(k) SpecialCleared Dec 3, 201023-day reviewClass II21 CFR 864.5425

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

Medtronic, Inc. · GGN Plasma, Coagulation Control

Cleared on Dec 3, 2010 as substantially equivalent to K042175 (Medtronic Vascular, 2004) after a 23-day review. Its family tree reaches back 2 generations to 1990.

Decided: Dec 3, 2010
Review: 23 days
Class: Class II
Product code: GGN
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K902081 (1990). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK902081 Clottrac (TM) Ibex Heparinase HR Act Cart./ControlHemotec, Inc. · 1990
1 generation backK042175 Heparinase HR Act Control, Model 550-12Medtronic Vascular · 2004
This deviceK103314 Clotrac Heparinase Test Cartidge (HTC) Coagulation ControlMedtronic, Inc. · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K902081	Clottrac (TM) Ibex Heparinase HR Act Cart./Control	Hemotec, Inc.	1990	—
−1	K042175	Heparinase HR Act Control, Model 550-12	Medtronic Vascular	2004	—
0 (this device)	K103314	Clotrac Heparinase Test Cartidge (HTC) Coagulation Control	Medtronic, Inc.	2010	—

FIG. 1 — Lineage of K103314, 1990–2010Source: 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 GGN? 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? (1)

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
*	K042175	Heparinase HR Act Control, Model 550-12 Summary page 1 …Code: JBP Classification: Class 11 Predicate Device CLOTtrac®I Hepaririase Test Cartridge (HTC) Coagulation Control (K042175) cleared on October 18, 2004. Comparison to Predicate Device A comparison of the modified device and…	Medtronic Vascular	2004	—

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?

The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 14.3 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All GGN devices

GGN Plasma, Coagulation Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · GGN

4in 2017

2007high 4 (2017) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GGN

96in 2017

2007high 441 (2013) · low 23 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GGN

1in 2019

2007high 4 (2010) · low 0 (2007)2026

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

Adverse event reports per year · GGN

4in 2018

2007high 37 (2009) · low 0 (2007)2025

MAUDE reports naming product code GGN, 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	3	47	0	0
2008	1	—	0	0
2009	2	—	0	37
2010	3	23	4	17
2011	2	—	1	30
2012	1	—	0	10
2013	3	441	3	9
2014	2	—	0	5
2015	0	—	0	10
2016	2	—	0	9
2017	4	96	0	11
2018	0	—	0	4
2019	0	—	1	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	2	—

What is it indicated for?

The CLOTtrac® Heparinase Test Cartridge (HTC) Coagulation Control is used to verify the performance of the ACT instrument and the Heparinase (HR-HTC) cartridges.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K103314 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103314: Clotrac Heparinase Test Cartidge (HTC) Coagulation Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103314

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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