510(k) Report

510(k) · Cleared

Cleared

Markers, Stainless Steel

K770802510(k) TraditionalCleared Jun 27, 197762-day reviewClass II21 CFR 878.4650

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

Cardio-Surgical, Inc. · KPK Marker, Ostia, Aorto-Saphenous Vein

Cleared on Jun 27, 1977 after a 62-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 27, 1977
Review
62 days
Class
Class II
Product code
KPK
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K770802Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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.

How does its category compare?

All KPK devices

KPK 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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

Recent decisions in KPK

The KPK category page

  • K971966Coronary Vein Graft Tag MarkerMed-Edge, Inc. · 1998
  • K895369Voss Graft MarkerVoss Medical Products · 1989
  • K864919Scanlan (TM) Vein/Graft HolderScanlan Intl., Inc. · 1987
  • K864101Cook (R) Vein Graft Ring MarkersCook, Inc. · 1986
  • K801637Fluoro-Mark Radiopaque Anatomical MKR.C.R. Bard, Inc. · 1980

https://510kreport.com/device/K770802 · printed Nov 4, 2026

Cite this page

510(k) Report. “K770802: Markers, Stainless Steel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K770802

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026