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Hyper-Sal 300F3502

by Pari Respiratory Equipment, Inc.

Hyper-Sal 300F3502 is a Class II device made by Pari Respiratory Equipment, Inc., cleared under FDA 510(k) K070498 on 26 Apr 2007 and listed in FDA GUDID since 17 Nov 2016 (UDI-DI 00744229235606), 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) K070498

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 Number00744229235606 UDI-DI Date17 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK070498 Date26 Apr 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K070498 decided 26 Apr 2007 Active
  • FDA GUDID UDI-DI 00744229235606 listed 17 Nov 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K070498
  2. Listed FDA GUDID 00744229235606

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Hyper-Sal
Generic name
Inhalation therapy saline solution, hypertonic
Model / reference
300F3502
Primary DI / UDI-DI
00744229235606
510(k) Number
FDA product code
CAF
GMDN term
Inhalation therapy saline solution, hypertonic
Device class
Class II
Regulation number
868.5630
GUDID distribution status
In Commercial Distribution

Related devices

Category: Inhalation therapy saline solution, hypertonic

Cleared under the same submission (K070498)

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

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)