510(k) Report

FDA applicant

Basf Venture Capital America, Inc.

Florham Park, NJ1 decision2012–20120 recalls

FDA records 1 decision for Basf Venture Capital America, Inc. (Florham Park, NJ) in 2012: 1 510(k) clearance. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 2 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

How often FDA has decided Basf Venture Capital America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Basf Venture Capital America, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FRODressing, Wound, Drug1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K122297Enluxtra Humifiber Wound DressingBasf Venture Capital America, Inc. · 2012

The one decision as Basf Venture Capital America, Inc. →