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Proneb Max 130F1002P12

by Pari Respiratory Equipment, Inc.

Proneb Max 130F1002P12 is a nebulizing system delivery set (FDA Class II; FDA product code CAF, Nebulizer (Direct Patient Interface)) made by Pari Respiratory Equipment, Inc., cleared under FDA 510(k) K191270 on 23 Jan 2020 and listed in FDA GUDID since 5 Jun 2020 (UDI-DI 00744229130055), 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) K191270

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 Number00744229130055 UDI-DI Date5 Jun 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK191270 Date23 Jan 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K191270 decided 23 Jan 2020 Active
  • FDA GUDID UDI-DI 00744229130055 listed 5 Jun 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K191270
  2. Listed FDA GUDID 00744229130055

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Proneb Max
Generic name
Nebulizing system delivery set, reusable
Model / reference
130F1002P12
Primary DI / UDI-DI
00744229130055
510(k) Number
FDA product code
CAF
GMDN term
Nebulizing system delivery set, reusable
Device class
Class II
Regulation number
868.5630
GUDID distribution status
In Commercial Distribution

Related devices

Category: Nebulizing system delivery set, reusable

Cleared under the same submission (K191270)

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

  • Over-the-counter
  • Lot / batch number
Other properties (13, all answered No)