Sims Intertech Hyperinflation Bag System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K952214 ↗

FDA Product Code

NHK

Device Class

Class II

Regulation

21 CFR Part 868.5905

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Resuscitation Bag Exhalation Filter

  Class II

  FDA 510(k) K883693 Active Cleared 30 Sep 1988

• 1ST Response Disposable Manometer

  Class II

  FDA 510(k) K961318 Active Cleared 17 Dec 1996

• 1ST Response (Tm) Infant Manual Resuscitator

  Class II

  FDA 510(k) K902733 Active Cleared 22 Aug 1990

• Intertech Newborn Hyperinflation Bag System

  Class II

  FDA 510(k) K894612 Active Cleared 8 Sep 1989

• Intertech/Inspiron (R) Medication Nebulizer Kit

  Class II

  FDA 510(k) K896923 Active Cleared 12 Mar 1990

• Disposable Anesthesia Breathing Circuits, Modified

  Class I

  FDA 510(k) K912065 Active Cleared 23 Oct 1991

See all devices from Intertech Resources, Inc. →

• What clinical settings is the Sims Intertech Hyperinflation Bag System intended for use in?

  The device is designed for controlled clinical environments where manual ventilation is required, such as operating rooms, emergency departments, or intensive care units. Its purpose is to deliver controlled lung inflation during mechanical ventilation or manual resuscitation, ensuring precise oxygenation and ventilation support in anesthesiology contexts.

• Is the Sims Intertech Hyperinflation Bag System reusable or single-use, and how should it be handled to maintain safety?

  The device is supplied as a reusable medical instrument, meaning it is intended for repeated use across multiple patients or procedures. However, it must be used in accordance with standard infection control protocols to ensure single-patient or emergency use safety, particularly when transitioning between patients or in high-risk environments.

• What types of sizes or models are available for the Sims Intertech Hyperinflation Bag System?

  The provided data does not specify exact sizes or model variants, but the device is classified under FDA regulation 21 CFR 868.5905 for manual, non-self-inflating resuscitators. For precise sizing or model details, refer to the manufacturer’s documentation or contact Intertech Resources, Inc. directly, as these may vary to accommodate different patient needs.

• How is the device sterilized, and what storage requirements should be followed?

  Since the device is reusable, it must undergo proper sterilization between uses to prevent cross-contamination. While the data does not specify sterilization methods, standard practices for reusable medical instruments—such as autoclaving or chemical sterilization—should be followed. Storage should occur in a clean, dry environment, protected from contamination, and in accordance with manufacturer guidelines to maintain functionality and safety.

• What regulatory pathway was followed for FDA clearance, and how does this affect its use?

  The device holds an FDA 510(k) clearance (K952214) under the Traditional 510(k) Review pathway, determined to be substantially equivalent to a predicate device. This clearance confirms its compliance with FDA standards for manual, non-self-inflating resuscitators in anesthesiology. Clinicians may rely on this clearance to validate its safety and effectiveness for controlled inflation of the lungs in designated clinical settings.