510(k) · Cleared
ClearedHeparin Assay Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · GGN Plasma, Coagulation Control
Cleared on Dec 1, 2010 as substantially equivalent to K894317 (Hemotec, Inc., 1989) and 1 other predicate after a 21-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Dec 1, 2010
- Review
- 21 days
- Class
- Class II
- Product code
- GGN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K894317 (1989). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894317 | Hemotec Hepcon HMS Coagulation System & Access. | Hemotec, Inc. | 1989 | 1 |
| −1 | K042206 | Purple/Black Heparin Assay Control | Medtronic Vascular | 2004 | — |
| 0 (this device) | K103313 | Heparin Assay Controls | Medtronic, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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? (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 | Decided |
|---|---|---|---|
| * | K894317 | Hemotec Hepcon HMS Coagulation System & Access.Summary page 1…864.5425 Product Code: GUN Classification: Class 11 Predicate Device Medtronic Heparin Assay Controls (K894317 and K042206) cleared on September 5, 1989 and October 1, 2004, respectively. Comparison to Predicate Device… | 1989 |
| * | K042206 | Purple/Black Heparin Assay ControlSummary page 1…Product Code: GUN Classification: Class 11 Predicate Device Medtronic Heparin Assay Controls (K894317 and K042206) cleared on September 5, 1989 and October 1, 2004, respectively. Comparison to Predicate Device A co… | 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 21 years and passes through 3 companies; a new generation was cleared every 15.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 4 other devices also cite its predicate K894317.
How does its category compare?
All GGN devicesGGN 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
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 HMS Plus and Heparin Assay Cartridges.
For In Vitro Diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103313 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103313: Heparin Assay Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103313
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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