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O-Pep 018F65

by Pari Respiratory Equipment, Inc.

O-Pep 018F65 is a Class II device made by Pari Respiratory Equipment, Inc., cleared under FDA 510(k) K150044 on 27 May 2016 and listed in FDA GUDID since 30 Jun 2017 (UDI-DI 00744229180142), 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) K150044

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 Number00744229180142 UDI-DI Date30 Jun 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK150044 Date27 May 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K150044 decided 27 May 2016 Active
  • FDA GUDID UDI-DI 00744229180142 listed 30 Jun 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K150044
  2. Listed FDA GUDID 00744229180142

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
O-Pep
Generic name
Positive pressure airway secretion-clearing device
Model / reference
018F65
Primary DI / UDI-DI
00744229180142
510(k) Number
FDA product code
BWF
GMDN term
Positive pressure airway secretion-clearing device
Device class
Class II
Regulation number
868.5690
GUDID distribution status
In Commercial Distribution

Related devices

Category: Positive pressure airway secretion-clearing device

Similar devices

Other devices filed under FDA product code BWF (Spirometer, Therapeutic (Incentive)).

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)