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eRapid 078F0600

by Pari Respiratory Equipment, Inc.

eRapid 078F0600 is an ultrasonic nebulizing system (FDA Class II; FDA product code CAF, Nebulizer (Direct Patient Interface)) made by Pari Respiratory Equipment, Inc., cleared under FDA 510(k) K112859 on 30 May 2012 and listed in FDA GUDID since 27 Sep 2016 (UDI-DI 00744229780052), 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) K112859

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 Number00744229780052 UDI-DI Date27 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK112859 Date30 May 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K112859 decided 30 May 2012 Active
  • FDA GUDID UDI-DI 00744229780052 listed 27 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K112859
  2. Listed FDA GUDID 00744229780052

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
eRapid
Generic name
Ultrasonic nebulizing system
Model / reference
078F0600
Primary DI / UDI-DI
00744229780052
510(k) Number
FDA product code
CAF
GMDN term
Ultrasonic nebulizing system
Device class
Class II
Regulation number
868.5630
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ultrasonic nebulizing system

Cleared under the same submission (K112859)

and 1 more cleared under K112859

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)