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Pari Baby

by Pari Holding Co.

510(k) K944152

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 NumberK944152 Date18 Nov 1994ClearedStatusActive

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  • Withdrawn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, 27 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 Pari Baby is a device classified under the product code CAF, which corresponds to a nebulizer for aerosol drug delivery. It was determined to be substantially equivalent to a legally marketed device through the traditional 510(k) clearance process.

The device was manufactured by Pari Holding Co. and received FDA clearance on November 18, 1994, under K944152. It is intended for use in the delivery of aerosolized medications, as indicated by its classification and the anesthesiology advisory committee review.

Other devices from Pari Holding Co.

See all devices from Pari Holding Co. →

Questions

AI-generated answers, 27 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 Pari Baby nebulizer used for?

    The Pari Baby nebulizer is intended for the delivery of aerosolized medications, as indicated by its classification under product code CAF and the anesthesiology advisory committee review, which supports its use in aerosol drug delivery applications.

  • How was the Pari Baby nebulizer cleared for market?

    The Pari Baby nebulizer received FDA clearance through the traditional 510(k) process on November 18, 1994, under K944152, after being determined substantially equivalent to a legally marketed device.

  • Who manufactures the Pari Baby nebulizer and where is it located?

    The Pari Baby nebulizer is manufactured by Pari Holding Co., located at 7493 Whitepine Rd., Richmond, VA 23237, United States, as specified in the device authorization records.