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Vortex 051F5000

by Pari Respiratory Equipment, Inc.

Vortex 051F5000 is a Class II device made by Pari Respiratory Equipment, Inc., cleared under FDA 510(k) K020944 on 9 May 2002 and listed in FDA GUDID since 12 Aug 2016 (UDI-DI 00744229510017), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K020944

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00744229510017 UDI-DI Date12 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK020944 Date9 May 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K020944 decided 9 May 2002 Active
  • FDA GUDID UDI-DI 00744229510017 listed 12 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K020944
  2. Listed FDA GUDID 00744229510017

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vortex
Generic name
Medicine chamber spacer, reusable
Model / reference
051F5000
Primary DI / UDI-DI
00744229510017
510(k) Number
FDA product code
CAF
GMDN term
Medicine chamber spacer, reusable
Device class
Class II
Regulation number
868.5630
GUDID distribution status
In Commercial Distribution

Related devices

Category: Medicine chamber spacer, reusable

Cleared under the same submission (K020944)

and 8 more cleared under K020944

Similar devices

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

Other devices from Pari Respiratory Equipment, Inc.

See all devices from Pari Respiratory Equipment, Inc. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)