FDA applicant

Prugen IP Holdings, Inc.

Scottsdale, AZ6 decisions2010–20120 recalls

FDA records 6 decisions for Prugen IP Holdings, Inc. (Scottsdale, AZ) from 2010 to 2012: 6 510(k) clearances. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 6 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 Prugen IP Holdings, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2012

2010high 3 (2010) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Prugen IP Holdings, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Prugen IP Holdings, 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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Other applicant names beginning “Prugen”

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

Prugen, Inc. 1

Prugen IP Holdings, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Prugen”