510(k) · Cleared
ClearedCarbomedics Handle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carbomedics, Inc. · DTJ Holder, Heart-Valve, Prosthesis
Cleared on Aug 27, 1996 as substantially equivalent to K942736 (Carbomedics, Inc., 1994) after an 84-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Aug 27, 1996
- Review
- 84 days
- Class
- Class I
- Product code
- DTJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K942736 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK942736 Carbomedics (R) Prosthetic Heart Valve Holder HandleCarbomedics, Inc. · 1994
- This deviceK962154 Carbomedics HandleCarbomedics, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK980016 Millennium Valve Introducer/Rotator HandleGenzyme Surgical Product (Genzyme Biosurgery) · 1998
Most influential descendants
Showing 1 of 1 · See all- K980016Millennium Valve Introducer/Rotator HandleGenzyme Surgical Product (Genzyme Biosurgery) · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942736 | Carbomedics (R) Prosthetic Heart Valve Holder Handle | Carbomedics, Inc. | 1994 | — |
| 0 (this device) | K962154 | Carbomedics Handle | Carbomedics, Inc. | 1996 | — |
| +1 | K980016 | Millennium Valve Introducer/Rotator Handle | Genzyme Surgical Product (Genzyme Biosurgery) | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K942736 | Carbomedics (R) Prosthetic Heart Valve Holder HandleSummary page 1…fective, and substantially equivalent in intended use, design, and function to the CarboMedics Valve Holder Handle (VH-100), approved for market on July 6, 1994, 510(k) #K942736. Common name of the device: Valve Holder Handle Trade name or Proprietary name: CarboMedics Handle Submitter and Contact person:… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980016 | Millennium Valve Introducer/Rotator Handle | 1998 | 0 |
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?
- Its one ancestor has no recall.
- 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 DTJ devicesDTJ 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
MAUDE reports naming product code DTJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CarboMedics Handle is intended for use with the CarboMedics Valve Holder (referred to herein as the "Valve Holder") for the purpose of assuring a firm grasp of the valve and to facilitate sewing ring exposure.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962154: Carbomedics Handle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962154
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026