510(k) Report

FDA product code · General hospital

Tunneled Catheter Remover

ODYClass II21 CFR 880.5970510(k) required2 decisions since 20070 recalls

2 FDA decisions since 2007. No recall names this code. The most-cited predicate is K063048, named by 1 later device.

To assist in the removal of tunneled long term catheter cuffs using a minimal invasive technique by seperating the tissue ingrowth cuff from the surrounding tissue. Following seperation of the cuff from the tissue, the catheter can be safely removed from the body.

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, general hospital panel

Twenty years of ODY 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 · ODY

1in 2012

2007: 12012: 1
2007high 1 (2007) · low 0 (2008)2026

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

2010: 1
2007high 1 (2010) · low 0 (2007)2025

MAUDE reports naming product code ODY, 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
20071—00
20080—00
20090—00
20100—01
20110—00
20121—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 — ODY by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in ODY? 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 predicates do ODY devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K063048Trans-Catheter ExtractorTran Pa-C, Inc. · 20071cites it

Which ODY devices have the deepest lineage?

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

  • K12226314.5-16.0 French Cuffed Catheter Removal Device, Symmetry Surgical Singel UseSymmetry Medical · 20121generation

What has FDA decided in ODY lately?

  • K12226314.5-16.0 French Cuffed Catheter Removal Device, Symmetry Surgical Singel UseSymmetry Medical · 2012
  • K063048Trans-Catheter ExtractorTran Pa-C, Inc. · 20071 recall

All 2 ODY decisions →

Related product codes

Other codes under 21 CFR 880.5970.

OKC Implanted Subcutaneous Securement CatheterPWR Catheter Repair KitLJS Catheter, Intravascular, Therapeutic…PZW Catheter Access Cover, Tamper-ResistantOMF Percutaneous, Implanted, Long-Term…