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510(k) K844963

VITAPEP by Vitalograph , Ltd. — Product Code BWF

K844963 is an FDA 510(k) premarket notification submitted by Vitalograph , Ltd. for the device "VITAPEP". The FDA issued a decision of Substantially Equivalent on June 7, 1985. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690. Vitalograph , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1985
Date Received
December 24, 1984
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 Vitalograph , Ltd.

  • K253293 — VitaloJAK Clinic (Model 7100) (December 3, 2025)
  • K000599 — VITALOGRAPH BASE STATION (September 8, 2000)
  • K991412 — VITALOGRAPH MICRO (February 4, 2000)
  • K943678 — ELECTRONIC FLOW METER (December 14, 1995)
  • K950854 — VITALOGRAPH 2110 SOFTWARE INTERFACE (October 12, 1995)
  • K946075 — VITALOGRAPH MODEL 2120 (August 4, 1995)
  • K942779 — DISPOSABLE BACTERIOLOGICAL FILTER (July 13, 1994)
  • K925085 — ESCORT SPIROMETER (August 12, 1993)
  • K930085 — VITALOGRAPH DATA STORAGE SPIROMETER (July 26, 1993)
  • K912412 — VITALOGRAPH SPIROTRAC III (October 15, 1991)

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