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Velox Nebulizer System

by Pari Respiratory Equipment, Inc.

510(k) K162785

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 NumberK162785 Date14 Apr 2017ClearedStatusActive

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  • Withdrawn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

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

Overview

AI-generated summary, 28 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 Velox Nebulizer System is a mobile vibrating membrane nebulizer designed for efficient aerosol therapy in the treatment of acute and chronic airway diseases such as COPD, asthma, and bronchitis. It provides high aerosol output with a large proportion of lung-deposable droplets and operates extremely quietly for discreet treatment.

This device is supplied by PARI Respiratory Equipment, Inc. and has received FDA 510(k) clearance with the product code CAF. The Velox Nebulizer System is intended for use in respiratory therapy applications, though specific details regarding sterility, single-use or reusable status, MRI safety, and storage conditions are not provided in the available data.

Similar devices

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

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