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510(k) K192000

D R Burton OxyPAP by D R Burton Healthcare, LLC — Product Code BWF

K192000 is an FDA 510(k) premarket notification submitted by D R Burton Healthcare, LLC for the device "D R Burton OxyPAP". The FDA issued a decision of Substantially Equivalent on February 19, 2020. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690. D R Burton Healthcare, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2020
Date Received
July 26, 2019
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 D R Burton Healthcare, LLC

  • K160636 — iPEP System and vPEP (August 3, 2016)

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)
  • 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)
  • K173918 — VersaPAP Positive Airway Pressure (PAP) Device (August 17, 2018)

FDA data resources