510(k) Report

FDA applicant

Dermaport, Inc.

Santa Clarita, CA2 decisions2007–20090 recalls

FDA records 2 decisions for Dermaport, Inc. (Santa Clarita, CA) from 2007 to 2009: 2 510(k) clearances. All are in product code MSD (Catheter, Hemodialysis, Implanted). Its devices cite 3 predicates, 1 of them its own earlier devices. No 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, gastroenterology and urology panel, where it files most

How often FDA has decided Dermaport, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007: 12009: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dermaport, 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?

  • MSDCatheter, Hemodialysis, Implanted2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K071202Dermaport Percutaneous Vascular Access System (Pvas)Dermaport, Inc. · 20071cites it

What has FDA decided for it lately?

  • K091760Dermaport Ported Vascular Access System (Pvas)Dermaport, Inc. · 2009
  • K071202Dermaport Percutaneous Vascular Access System (Pvas)Dermaport, Inc. · 2007

All 2 as Dermaport, Inc. →