Home / 510(k) Clearances / K150044

510(k) K150044

O-PEP by Pari Respiratory Equipment, Inc. — Product Code BWF

K150044 is an FDA 510(k) premarket notification submitted by Pari Respiratory Equipment, Inc. for the device "O-PEP". The FDA issued a decision of Substantially Equivalent on May 27, 2016. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690. Pari Respiratory Equipment, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2016
Date Received
January 12, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Therapeutic (Incentive)
Device Class
Class II
Regulation Number
868.5690
Review Panel
AN
Submission Type

Other clearances by Pari Respiratory Equipment, Inc.

  • K251572 — eRapid with eTrack System (December 19, 2025)
  • K223840 — eRapid Nebulizer System (August 11, 2023)
  • K191270 — Proneb Max (January 23, 2020)
  • K162785 — Velox Nebulizer System (April 14, 2017)
  • K112859 — ERAPID NEBULIZER SYSTEM (May 30, 2012)
  • K092560 — PARI SINUS (May 6, 2010)
  • K100380 — ALTERA NEBULIZER SYSTEM, MODEL 678G1002 (February 22, 2010)
  • K092918 — PARI VIOS (February 4, 2010)
  • K090829 — PARI PEP S (July 21, 2009)

Other clearances for product code BWF

  • K241152 — InSee (August 21, 2025)
  • K233855 — AllPEP (February 2, 2024)
  • K221058 — LungTrainer (MD2 & MD3) (July 5, 2023)
  • K222018 — Breathe+ (June 2, 2023)
  • K220565 — Hudson RCI Triflo II Incentive Deep Breathing Exerciser (October 25, 2022)
  • K203378 — Pulsehaler (March 31, 2021)
  • K192000 — D R Burton OxyPAP (February 19, 2020)
  • K181660 — Acapella Choice Blue Vibratory PEP Device (October 24, 2019)
  • K183108 — Combined Aerobika OPEP and VersaPAP device (August 16, 2019)
  • K182847 — Hudson RCI Voldyne Volumetric Exerciser (July 1, 2019)

FDA data resources