510(k) Report

510(k) · Cleared

Cleared

Graft Marker Ring

K001915510(k) TraditionalCleared Apr 27, 2001308-day reviewClass II21 CFR 870.3450

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

T. Korossurgical Instruments Corp. · MAB Marker, Cardiopulmonary Bypass (Vein Marker)

Cleared on Apr 27, 2001 after a 308-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Apr 27, 2001
Review
308 days
Class
Class II
Product code
MAB
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K001915Source: 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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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, 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 MAB devices

MAB Marker, Cardiopulmonary Bypass (Vein Marker): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MAB

FDA has decided no MAB device since 2007.

Median 510(k) review, days · MAB

Too few MAB 510(k)s in any year since 2007 to give a median.

Recalls per year · MAB

No recall names MAB since 2007.

Adverse event reports per year · MAB

No MAUDE report names MAB 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—

More from T. Korossurgical Instruments Corp.

27 FDA decisions under this applicant name. See the company

  • K002755Non-Absorbing Sternatomy Monofilament SutureT. Korossurgical Instruments Corp. · 2000
  • K954016Videoscope W/Irrigation SheathT. Korossurgical Instruments Corp. · 1996
  • K953998Discetome Tissue AspiratorT. Korossurgical Instruments Corp. · 1995
  • K954014Percutaneous Discectomy Cannula SystemT. Korossurgical Instruments Corp. · 1995
  • K954052Arthroscopic Grasper, Cup Forceps and CurettesT. Korossurgical Instruments Corp. · 1995

Recent decisions in MAB

The MAB category page

  • K052642Suturing WasherFirst Call, Inc. · 2006
  • K894268C.a.B. RingMedi-Sharp, Inc. · 1989

https://510kreport.com/device/K001915 · printed Nov 5, 2026

Cite this page

510(k) Report. “K001915: Graft Marker Ring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001915

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