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510(k) K900754

RESPIREX 2 by Diemolding Corp. — Product Code BWF

K900754 is an FDA 510(k) premarket notification submitted by Diemolding Corp. for the device "RESPIREX 2". The FDA issued a decision of Substantially Equivalent on March 15, 1990. 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
March 15, 1990
Date Received
February 16, 1990
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.

  • K962749 — THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PO (October 10, 1996)
  • 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)
  • 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