Inspiratory Resistor Kit

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K831142 ↗

FDA Product Code

BWF

Device Class

Class II

Regulation

21 CFR Part 868.5690

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• T-Pieces Connectors

  Class I

  FDA 510(k) K860887 Active Cleared 19 Mar 1986

• Nasal Cannula W/2M & 5M Tubing

  Class I

  FDA 510(k) K860872 Active Cleared 19 Mar 1986

• Inspiratory Force Mont Kit/Manifold/Meter/Tubing

  Class II

  FDA 510(k) K873498 Active Cleared 9 Mar 1988

• Asthmakit

  Class II

  FDA 510(k) K874047 Active Cleared 29 Feb 1988

• Non-Rebreathing T Piece

  Class II

  FDA 510(k) K790820 Active Cleared 4 May 1979

• HOO2D Seat-Infant

  Class I

  FDA 510(k) K820640 Active Cleared 26 Mar 1982

See all devices from Dhd Medical Products Div. Diemolding Corp. →

• What is the Inspiratory Resistor Kit primarily used for in clinical settings?

  The Inspiratory Resistor Kit is designed as a spirometer for respiratory training, helping patients improve lung function through controlled breathing exercises. It is commonly used in pulmonary rehabilitation programs or postoperative recovery to strengthen respiratory muscles and enhance breathing efficiency.

• Is the Inspiratory Resistor Kit intended for single-use or reusable applications?

  The Inspiratory Resistor Kit is explicitly described as a reusable device. This means it is designed for repeated use in clinical settings, provided proper cleaning and maintenance protocols are followed.

• What regulatory pathway was followed for FDA clearance of this device?

  The Inspiratory Resistor Kit received FDA clearance through a 510(k) submission, classified as Substantially Equivalent (SESE) under the Traditional review pathway. It falls under Product Code BWF and is regulated under 21 CFR 868.5690, with an associated advisory committee in Anesthesiology. The clearance number is K831142, granted on June 3, 1983.

• Are there multiple sizes or models available for the Inspiratory Resistor Kit?

  Yes, the data indicates multiple FEI numbers (e.g., 3013557562, 3011689956, etc.) associated with the Inspiratory Resistor Kit, suggesting the existence of various models or configurations. These likely correspond to different resistance levels or component variations to accommodate different patient needs.

• Is there any information provided about sterility or MRI safety for this device?

  The documentation does not specify any details regarding sterility requirements or MRI safety for the Inspiratory Resistor Kit. Clinicians should follow standard infection control protocols for reusable medical devices and verify MRI compatibility with their specific MRI system if needed.