Cleared Traditional

K952021 - PRIMA HYUPERINFLATION SYSTEM

K952021 is the FDA 510(k) clearance for PRIMA HYUPERINFLATION SYSTEM by Prima, Inc.. It is a Class 2 Anesthesiology device (product code BZR) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K952021 · Prima, Inc. · Anesthesiology device
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May 1995
Decision
24d
Days
Class 2
Risk

K952021 is an FDA 510(k) clearance for the PRIMA HYUPERINFLATION SYSTEM. Classified as Mixer, Breathing Gases, Anesthesia Inhalation (product code BZR), Class II - Special Controls.

Submitted by Prima, Inc. (Cleveland, US). The FDA issued a Cleared decision on May 22, 1995 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5330 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Prima, Inc. devices

Submission Details

510(k) Number K952021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1995
Decision Date May 22, 1995
Days to Decision 24 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 140d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZR Mixer, Breathing Gases, Anesthesia Inhalation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BZR Mixer, Breathing Gases, Anesthesia Inhalation

All 13
Devices cleared under the same product code (BZR) and FDA review panel - the closest regulatory comparables to K952021.
Quality Mix Blender, Oxymixer
K221494 · Dehas Medical Systems GmbH · Jan 2023
Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50
K202480 · Parker Hannifin · Apr 2021
Equinox Advantage
K173205 · O-Two Medical Technologies, Inc. · Aug 2018
MERIDIAN MEDICAL SYSTEMS HYPER INFLATION BAY SYST
K925591 · Merit Medical Systems, Inc. · Sep 1993
OHMEDA OXYGEN BLENDER
K853905 · Ohmeda Medical · Oct 1985
SECHRIST AIR-OXYGEN MIXER & ANCILLARY
K841789 · Shiley, Inc. · Jul 1984