510(k) · Cleared
Recalled · Class II · 2024Trans-Catheter Extractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tran Pa-C, Inc. · ODY Tunneled Catheter Remover
Cleared on Sep 14, 2007 after a 345-day review. The FDA summary names no predicate by number. 1 later device descends from it. It has been recalled once.
- Decided
- Sep 14, 2007
- Review
- 345 days
- Class
- Class II
- Product code
- ODY
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK063048 Trans-Catheter ExtractorTran Pa-C, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK122263 14.5-16.0 French Cuffed Catheter Removal Device, Symmetry Surgical…Symmetry Medical · 2012
Most influential descendants
Showing 1 of 1 · See all- K12226314.5-16.0 French Cuffed Catheter Removal Device, Symmetry Surgical Singel UseSymmetry Medical · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063048 | Trans-Catheter Extractor | Tran Pa-C, Inc. | 2007 | — |
| +1 | K122263 | 14.5-16.0 French Cuffed Catheter Removal Device, Symmetry Surgical Singel Use | Symmetry Medical | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 ODY? 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?
The FDA summary names no predicate by number.
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 |
|---|---|---|---|
| K122263 | 14.5-16.0 French Cuffed Catheter Removal Device, Symmetry Surgical Singel Use | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 11, 2024 | Class II | Z-2559-2024 | No Marketing Application | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K122263 (Symmetry Medical, 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ODY devicesODY Tunneled Catheter Remover: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · ODY
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · ODY
Too few ODY 510(k)s in any year since 2007 to give a median.
Recalls per year · ODY
No recall names ODY since 2007.
Adverse event reports per year · ODY
1in 2010
MAUDE reports naming product code ODY, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 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 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Trans Catheter Extractor is a catheter accessory device intended for
minimally invasive removal of tunneled long term catheters. The Trans Catheter
Extractor is indicated for use with tunneled, double lumen Permcath catheters
with cuff sizes ranging from 10.8 french to 14.5 french.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063048 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063048: Trans-Catheter Extractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063048
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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