510(k) Report

510(k) · Cleared

Cleared

Carbomedics (R) Prosthetic Heart Valve Holder Handle

K942736510(k) TraditionalCleared Jul 6, 199426-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. · DTJ Holder, Heart-Valve, Prosthesis

Cleared on Jul 6, 1994 after a 26-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Jul 6, 1994
Review
26 days
Class
Class I
Product code
DTJ
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1998: 1 descendant cleared1990200020102020
  1. This deviceK942736 Carbomedics (R) Prosthetic Heart Valve Holder HandleCarbomedics, Inc. · 1994
  2. Descendant · cites it directly · 1 of its ownK962154 Carbomedics HandleCarbomedics, Inc. · 1996
  3. Descendant · 2 generations on · 0 of its ownK980016 Millennium Valve Introducer/Rotator HandleGenzyme Surgical Product (Genzyme Biosurgery) · 1998

Most influential descendants

Showing 2 of 2 · See all
  • K962154Carbomedics HandleCarbomedics, Inc. · 1996 · cites it directly1descendant
  • K980016Millennium Valve Introducer/Rotator HandleGenzyme Surgical Product (Genzyme Biosurgery) · 1998 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K942736Carbomedics (R) Prosthetic Heart Valve Holder HandleCarbomedics, Inc.1994—
+1K962154Carbomedics HandleCarbomedics, Inc.1996—
+2K980016Millennium Valve Introducer/Rotator HandleGenzyme Surgical Product (Genzyme Biosurgery)1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199810
FIG. 1 — Lineage of K942736, 1994–1998Source: 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 DTJ? 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? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K962154Carbomedics HandleCarbomedics, Inc.19961

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, K962154 (Carbomedics, Inc., 1996) has gone furthest, with 1 descendant of its own.

How does its category compare?

All DTJ devices

DTJ Holder, Heart-Valve, Prosthesis: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTJ

FDA has decided no DTJ device since 2007.

Median 510(k) review, days · DTJ

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

Recalls per year · DTJ

No recall names DTJ since 2007.

Adverse event reports per year · DTJ

2in 2023

2023: 2
2007high 2 (2023) · low 0 (2007)2025

MAUDE reports naming product code DTJ, 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—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—02
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 DTJ

The DTJ category page

  • K962154Carbomedics HandleCarbomedics, Inc. · 1996
  • K960169Carbomedics Valve TesterCarbomedics, Inc. · 19961 recall
  • K944214Baxter Handle Model 1150Baxter Edwards · 1995
  • K880052Edwards-Duromedics Mitral Valve RotatorBaxter Healthcare Corp · 1988
  • K871596Ionescu-Shiley Pericardial Xenograft (Isu)Shiley, Inc. · 1987

https://510kreport.com/device/K942736 · printed Nov 6, 2026

Cite this page

510(k) Report. “K942736: Carbomedics (R) Prosthetic Heart Valve Holder Handle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942736

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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