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510(k) K962749

THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT by Diemolding Corp. — Product Code BWF

K962749 is an FDA 510(k) premarket notification submitted by Diemolding Corp. for the device "THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT". The FDA issued a decision of Substantially Equivalent on October 10, 1996. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690. Diemolding Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1996
Date Received
July 15, 1996
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 Diemolding Corp.

  • K961455 — MEDSHIELD/AEROCHAMBER (July 25, 1996)
  • K902713 — ACCESS. KIT FOR THE BIOSURGE SYNCHRONOUS AUTOTRANS (July 25, 1990)
  • K902114 — CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR (July 18, 1990)
  • K900754 — RESPIREX 2 (March 15, 1990)
  • K893791 — BREATHING MOUTHPIECE (June 23, 1989)
  • K781759 — RESCAL (November 27, 1978)
  • K780750 — O2 CONNECTOR (July 27, 1978)
  • K770369 — VACON TM (March 1, 1977)
  • K760931 — I.V. DRIP MONITOR ALARM DEVICE, MONIFLO (January 5, 1977)
  • K760636 — ORTHOMIX (October 5, 1976)

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