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Dwfritz ASM2000

by Dwfritz Automation, Inc. 510(k)

Active United States

510(k) K213894

Overview

The Dwfritz ASM2000 is a surgical face mask designed to protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter when properly worn. It is classified as a non‑sterile, single‑use device intended for use in clinical settings.

The mask is supplied as a non‑sterile, single‑use product and is cleared under FDA 510(k) submission K213894 with a traditional clearance type. It is marketed by Dwfritz Automation, Inc. in Wilsonville, Oregon, United States, and carries the product code FXX.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK213894 Date14 Mar 2022ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FXX
Device Class
Class II
Regulation
21 CFR Part 878.4040
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent