510(k) · Cleared
ClearedHeparinase HR Act Control, Model 550-12
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · GGN Plasma, Coagulation Control
Cleared on Oct 18, 2004 as substantially equivalent to K902081 (Hemotec, Inc., 1990) after a 68-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.
- Decided
- Oct 18, 2004
- Review
- 68 days
- Class
- Class II
- Product code
- GGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902081 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK902081 Clottrac (TM) Ibex Heparinase HR Act Cart./ControlHemotec, Inc. · 1990
- This deviceK042175 Heparinase HR Act Control, Model 550-12Medtronic Vascular · 2004
- Descendant · cites it directly · 0 of its ownK103314 Clotrac Heparinase Test Cartidge (HTC) Coagulation ControlMedtronic, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K103314Clotrac Heparinase Test Cartidge (HTC) Coagulation ControlMedtronic, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902081 | Clottrac (TM) Ibex Heparinase HR Act Cart./Control | Hemotec, Inc. | 1990 | — |
| 0 (this device) | K042175 | Heparinase HR Act Control, Model 550-12 | Medtronic Vascular | 2004 | — |
| +1 | K103314 | Clotrac Heparinase Test Cartidge (HTC) Coagulation Control | Medtronic, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K902081 | Clottrac (TM) Ibex Heparinase HR Act Cart./ControlSummary page 1…mmon Name: Activated Whole Blood Clotting Time Classification: Class LI Predicate Devices: Heparinase HR ACT Control K902081 Device Description: The CLOTtrac® HTC Control is an in vitro diagnostic device. This control is intended to verify the performa… | 1990 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103314 | Clotrac Heparinase Test Cartidge (HTC) Coagulation Control | 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 no recall.
- Of its descendants, K103314 (Medtronic, Inc., 2010) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GGN devicesGGN Plasma, Coagulation Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GGN
4in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · GGN
96in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GGN
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GGN
4in 2018
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?
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/K042175 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042175: Heparinase HR Act Control, Model 550-12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042175
Report an extraction error
Are you the manufacturer?
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