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Microcirrus Medical Nebulizer

by Dhd Medical Products Div. Diemolding Corp.

510(k) K881935

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK881935 Date22 Jun 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CAF
Device Class
Class II
Regulation
21 CFR Part 868.5630
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Microcirrus Medical Nebulizer is a medical device classified as a nebulizer with a direct patient interface. It is designed to deliver medication in the form of a mist to the respiratory system.

This device is identified by FDA 510(k) number K881935. It is categorized under the anesthesiology medical specialty and has received FDA 510(k) clearance.

Other devices from Dhd Medical Products Div. Diemolding Corp.

See all devices from Dhd Medical Products Div. Diemolding Corp. →

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Microcirrus Medical Nebulizer?

    The Microcirrus Medical Nebulizer is designed to deliver medication to a patient's respiratory system by converting liquid medication into a fine mist for inhalation.

  • How is this device classified for regulatory purposes?

    The device is classified under the anesthesiology medical specialty and has received FDA 510(k) clearance under the number K881935, confirming it is substantially equivalent to existing devices.

  • Who is the manufacturer of the Microcirrus Medical Nebulizer?

    The device is manufactured by Dhd Medical Products, a division of Diemolding Corp., located in Canastota, New York.