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U-Right Compressor Nebulizer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K121969

by Taidoc Technology Corporation

Identifiers

510(k) Number
K121969 FDA 510(k)
FDA Product Code
CAF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5630 FDA 510(k)
Regulation Number
868.5630 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

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.

Frequently asked questions

What type of medication delivery does the U‑Right Compressor Nebulizer provide?

The device is a compressor nebulizer that creates an aerosol with a mass median aerodynamic diameter of about 2.5 µm, allowing fine particles to reach the lower airways for respiratory therapy. This particle size is derived from the DC micropump technology described in the data, indicating its suitability for delivering inhaled drugs.

Is the U‑Right Compressor Nebulizer intended for single‑use or can it be reused?

According to the description, the nebulizer is supplied as a reusable medical instrument. The data explicitly states it requires proper maintenance and storage, which implies it is designed for multiple uses in a clinical environment rather than being a disposable, single‑use product.

In what clinical settings is the U‑Right Compressor Nebulizer meant to be used?

The device is intended for use in clinical settings, including anesthesia applications. This is directly mentioned in the description, indicating that it can be employed wherever aerosolized medication is needed, such as operating rooms or other patient‑care areas where anesthesia support is provided.

How is the U‑Right Compressor Nebulizer supplied and what are the storage requirements?

The nebulizer is supplied as a complete, reusable instrument. While the exact packaging details are not listed, the data notes that it requires proper maintenance and storage per the manufacturer’s guidelines, meaning it should be kept in a clean, dry environment and serviced according to the provided instructions to ensure continued performance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: U-RIGHT COMPRESSOR NEBULIZER (K121969) — FDA 510(k) | Innolitics, Nebulizer - TaiDoc.com, Nebulizer Compressor TD-7014 - TaiDoc.com, Nebulizer - URight Medical, U-RIGHT COMPRESSOR NEBULIZER 510 (k) K121969 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Taidoc Technology Corporation

Sources (1)

  • FDA 510(k) K121969 24 fields · synced Sep 19, 2026