510(k) Report

FDA applicant

Tran Pa-C, Inc.

Orlando, FL1 decision2007–20071 recall

FDA records 1 decision for Tran Pa-C, Inc. (Orlando, FL) in 2007: 1 510(k) clearance. All are in product code ODY (Tunneled Catheter Remover). 1 recall is linked to its devices.

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

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Tran Pa-C, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

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

2026 so far, outlined.

Recalls per year

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Tran Pa-C, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ODYTunneled Catheter Remover1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

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

What has FDA decided for it lately?

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

The one decision as Tran Pa-C, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K063048Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Jun 11, 2024Class II