510(k) Report

FDA applicant

Nepera, Inc.

Harriman, NY1 decision1988–19880 recalls

FDA records 1 decision for Nepera, Inc. (Harriman, NY) in 1988: 1 510(k) clearance. All are in product code NAD (Dressing, Wound, Occlusive). 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 Nepera, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nepera, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Nepera, 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?

  • NADDressing, Wound, Occlusive1decision

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.

  • K881731AD-Heal (TM) Wound DressingNepera, Inc. · 19881cites it

What has FDA decided for it lately?

  • K881731AD-Heal (TM) Wound DressingNepera, Inc. · 1988

The one decision as Nepera, Inc. →