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Nebulizer SET-2C7105

by Travenol Laboratories, S.A.

510(k) K772222

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 NumberK772222 Date22 Dec 1977ClearedStatusActive

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  • Withdrawn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, 24 Sep 2026

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

A nebulizer set is a device used to convert liquid medication into a fine mist for inhalation therapy. This specific model, the Nebulizer Set-2C7105, is designed for respiratory delivery of aerosolized medications.

It is supplied as a non-sterile, reusable device intended for use in clinical settings such as hospitals or clinics. The device has received FDA 510(k) clearance (K772222) and is classified under product code CAF with an anesthesiology advisory committee review. It is not indicated as sterile, single-use, or MRI-safe in the provided data.

Other devices from Travenol Laboratories, S.A.

See all devices from Travenol Laboratories, S.A. →

Questions

AI-generated answers, 24 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 Nebulizer Set-2C7105 used for?

    The Nebulizer Set-2C7105 is used to convert liquid medication into a fine mist for inhalation therapy, specifically designed for respiratory delivery of aerosolized medications in clinical environments such as hospitals or clinics.

  • Is the Nebulizer Set-2C7105 sterile or single-use?

    The Nebulizer Set-2C7105 is supplied as a non-sterile, reusable device and is not indicated as sterile or single-use in the provided data, meaning it is intended for multiple uses after appropriate cleaning between patients.

  • What regulatory clearance does the Nebulizer Set-2C7105 have?

    The Nebulizer Set-2C7105 has received FDA 510(k) clearance under submission number K772222, with a decision date of December 22, 1977, and is classified under product code CAF with review by the anesthesiology advisory committee.