Prima Hyuperinflation System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K952021 ↗

FDA Product Code

BZR

Device Class

Class II

Regulation

21 CFR Part 868.5330

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Prima Mapleson D Circuit

  Class I

  FDA 510(k) K952017 Active Cleared 22 May 1995

• Prima, Inc. Connectors and Airway Extensions

  Class I

  FDA 510(k) K944534 Active Cleared 29 Nov 1994

• Prima Adult Gas Sampling Circuits

  Class I

  FDA 510(k) K952019 Active Cleared 22 May 1995

• Prima, Inc. Corrugated Tubing

  Class I

  FDA 510(k) K944531 Active Cleared 2 Dec 1994

• Prima Coaxial Circuits

  Class I

  FDA 510(k) K952018 Active Cleared 22 May 1995

• Prima Pediatric Anesthesia Circuits

  Class I

  FDA 510(k) K952020 Active Cleared 22 May 1995

See all devices from Prima, Inc. →

• What is the primary function of the Prima Hyuperinflation System?

  This device functions as a breathing gases mixer specifically designed for use in anesthesia inhalation. It is engineered to facilitate the controlled delivery of gases during clinical procedures.

• How is the Prima Hyuperinflation System classified for regulatory purposes?

  The system is classified as a Class 2 medical device under regulation number 868.5330. It has received FDA 510(k) clearance through the traditional pathway, indicating it has been found substantially equivalent to legally marketed predicate devices.

• Which medical specialty is this device intended for?

  The Prima Hyuperinflation System is categorized under the anesthesiology medical specialty. It is designed to meet the specific requirements for gas delivery within clinical anesthesia settings.