510(k) · Cleared
ClearedCoronary Vein Graft Tag Marker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Med-Edge, Inc. · KPK Marker, Ostia, Aorto-Saphenous Vein
Cleared on Jan 26, 1998 after a 243-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Jan 26, 1998
- Review
- 243 days
- Class
- Class II
- Product code
- KPK
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK971966 Coronary Vein Graft Tag MarkerMed-Edge, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK050384 Kapp Bari-Ring, Model KS-BR-2005Kapp Surgical Instrument, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK072216 Kapp Bari-Ring Endoscopic Marker, Model K-9536Kapp Surgical Instrument, Inc. · 2007 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971966 | Coronary Vein Graft Tag Marker | Med-Edge, Inc. | 1998 | — |
| +1 | K050384 | Kapp Bari-Ring, Model KS-BR-2005 | Kapp Surgical Instrument, Inc. | 2006 | — |
| +2 | K072216 | Kapp Bari-Ring Endoscopic Marker, Model K-9536 | Kapp Surgical Instrument, Inc. | 2007 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KPK? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050384 | Kapp Bari-Ring, Model KS-BR-2005 | 2006 | 1 |
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, K050384 (Kapp Surgical Instrument, Inc., 2006) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KPK devicesKPK Marker, Ostia, Aorto-Saphenous Vein: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPK
FDA has decided no KPK device since 2007.
Median 510(k) review, days · KPK
Too few KPK 510(k)s in any year since 2007 to give a median.
Recalls per year · KPK
No recall names KPK since 2007.
Adverse event reports per year · KPK
No MAUDE report names KPK since 2007.
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 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 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 | — | 0 | — |
What is it indicated for?
A radiopaque marker used to identify the coronary vein graft which is commonly used to revascularize the blood supply to the heart. The marker is attached to the distal and / or proximal anastomosis sites of the graft by thie surgeon during the CABG procedure. The marker can subsequently be used by the cardiologist during cardiac catheterization as a landmark to easily identify the anastomosis site of the vein graft utilizing fluoroscopy.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971966 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971966: Coronary Vein Graft Tag Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971966
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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