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U-Right Compressor Nebulizer

by Taidoc Technology Corporation

510(k) K121969

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK121969 Date28 Feb 2013ClearedStatusActive

Official records

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  • Withdrawn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

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 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 U-Right Compressor Nebulizer is a compressor nebulizer designed for delivering aerosolized medication directly to patients via a direct patient interface. It operates using DC micropump technology to generate fine particles with a mass median aerodynamic diameter (MMAD) of approximately 2.5 micrometers, ensuring efficient drug delivery for respiratory treatments.

This device is supplied as a reusable medical instrument and is intended for use in clinical settings, including anesthesia applications. It requires proper maintenance and storage as outlined in manufacturer guidelines. The U-Right Compressor Nebulizer holds an FDA 510(k) clearance (K121969) under the classification of Nebulizer (Direct Patient Interface), with a decision date of February 28, 2013.

Similar devices

Other devices filed under FDA product code CAF (Nebulizer (Direct Patient Interface)).

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