510(k) Report

510(k) · Cleared

Cleared

Carbomedics Exended Mitral Rotator

K951368510(k) TraditionalCleared Jun 20, 199585-day reviewClass I21 CFR 870.3935

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

Carbomedics, Inc. · MOP Rotator, Prosthetic Heart Valve

Cleared on Jun 20, 1995 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Jun 20, 1995
Review
85 days
Class
Class I
Product code
MOP
Recalls
None
Predicates
0

3 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1998: 2 descendants cleared1996: 1 descendant cleared1995200020052010201520202025
  1. This deviceK951368 Carbomedics Exended Mitral RotatorCarbomedics, Inc. · 1995
  2. Descendant · cites it directly · 0 of its ownK980016 Millennium Valve Introducer/Rotator HandleGenzyme Surgical Product (Genzyme Biosurgery) · 1998
  3. Descendant · cites it directly · 0 of its ownK974648 Sulzer Carbomedics Low Profile Mitral RotatorSulzer Carbomedics, Inc. · 1998
  4. Descendant · cites it directly · 0 of its ownK960923 Carbomedics Mitral RotatorCarbomedics, Inc. · 1996

Most influential descendants

Showing 3 of 3 · See all
  • K980016Millennium Valve Introducer/Rotator HandleGenzyme Surgical Product (Genzyme Biosurgery) · 1998 · cites it directly0descendants
  • K974648Sulzer Carbomedics Low Profile Mitral RotatorSulzer Carbomedics, Inc. · 1998 · cites it directly0descendants
  • K960923Carbomedics Mitral RotatorCarbomedics, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951368Carbomedics Exended Mitral RotatorCarbomedics, Inc.1995—
+1K980016Millennium Valve Introducer/Rotator HandleGenzyme Surgical Product (Genzyme Biosurgery)1998—
+1K974648Sulzer Carbomedics Low Profile Mitral RotatorSulzer Carbomedics, Inc.1998—
+1K960923Carbomedics Mitral RotatorCarbomedics, Inc.1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199820
FIG. 1 — Lineage of K951368, 1995–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

Planning a device in MOP? 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
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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? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K980016Millennium Valve Introducer/Rotator HandleGenzyme Surgical Product (Genzyme Biosurgery)19980
K974648Sulzer Carbomedics Low Profile Mitral RotatorSulzer Carbomedics, Inc.19980
K960923Carbomedics Mitral RotatorCarbomedics, Inc.19960

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, K980016 (Genzyme Surgical Product (Genzyme Biosurgery), 1998) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MOP devices

MOP Rotator, Prosthetic Heart Valve: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MOP

FDA has decided no MOP device since 2007.

Median 510(k) review, days · MOP

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

Recalls per year · MOP

No recall names MOP since 2007.

Adverse event reports per year · MOP

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2025

MAUDE reports naming product code MOP, not matched to any one device; reports are not rates.

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—01
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 Carbomedics, Inc.

27 FDA decisions under this applicant name. See the company

  • K970375Annuloflo SystemCarbomedics, Inc. · 1997
  • K964665Vascutek Gelweave Vascular Graft (Bifurcated Configuration)Carbomedics, Inc. · 1997
  • K962154Carbomedics HandleCarbomedics, Inc. · 1996
  • K960923Carbomedics Mitral RotatorCarbomedics, Inc. · 1996
  • K960706Vascutek Vascusoft Plus Vascular GraftCarbomedics, Inc. · 1996

Recent decisions in MOP

The MOP category page

  • K980016Millennium Valve Introducer/Rotator HandleGenzyme Surgical Product (Genzyme Biosurgery) · 1998
  • K974648Sulzer Carbomedics Low Profile Mitral RotatorSulzer Carbomedics, Inc. · 1998
  • K960923Carbomedics Mitral RotatorCarbomedics, Inc. · 1996

https://510kreport.com/device/K951368 · printed Nov 4, 2026

Cite this page

510(k) Report. “K951368: Carbomedics Exended Mitral Rotator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951368

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