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510(k) K160636

iPEP System and vPEP by D R Burton Healthcare, LLC — Product Code BWF

K160636 is an FDA 510(k) premarket notification submitted by D R Burton Healthcare, LLC for the device "iPEP System and vPEP". The FDA issued a decision of Substantially Equivalent on August 3, 2016. 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
August 3, 2016
Date Received
March 7, 2016
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

  • K192000 — D R Burton OxyPAP (February 19, 2020)

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