510(k) Report

FDA applicant

Vitalitec Int'L., Inc.

Plymouth, MA1 decision1998–19980 recalls

FDA records 1 decision for Vitalitec Int'L., Inc. (Plymouth, MA) in 1998: 1 510(k) clearance. All are in product code FZP (Clip, Implantable). Its devices cite 5 predicates, 0 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, general and plastic surgery panel, where it files most

How often FDA has decided Vitalitec Int'L., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Vitalitec Int'L., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Vitalitec Int'L., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vitalitec Int'L., Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FZPClip, Implantable1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 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.

  • K981645Titanium Hemostatic ClipVitalitec Int'L., Inc. · 19983cite it

What has FDA decided for it lately?

  • K981645Titanium Hemostatic ClipVitalitec Int'L., Inc. · 1998

The one decision as Vitalitec Int'L., Inc. →

Other applicant names beginning “Vitalitec”

FDA records each applicant name separately; these may or may not be the same firm.

Vitalitec Medizintechnik GmbH 1