510(k) Report

FDA product code · Cardiovascular

Marker, Cardiopulmonary Bypass (Vein Marker)

MABClass II21 CFR 870.3450510(k) required3 decisions since 19890 recalls

3 FDA decisions since 1989. No recall names this code.

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

FIG. A — Illustration, cardiovascular panel

Twenty years of MAB at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

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—
FIG. 1 — MAB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MAB? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which MAB devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K052642Suturing WasherFirst Call, Inc. · 20061generation

What has FDA decided in MAB lately?

  • K052642Suturing WasherFirst Call, Inc. · 2006
  • K001915Graft Marker RingT. Korossurgical Instruments Corp. · 2001
  • K894268C.a.B. RingMedi-Sharp, Inc. · 1989

All 3 MAB decisions →

Related product codes

Other codes under 21 CFR 870.3450.

DSY Prosthesis, Vascular Graft, Of 6mm And Greater…MAL Graft, Vascular, Synthetic/Biologic CompositeDYF Prosthesis, Vascular Graft, Of Less Then 6mm…MZY Graft, Vascular, Stainless Steel Tunneler