Cleared Traditional

K952021 - PRIMA HYUPERINFLATION SYSTEM

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

K952021 · Prima, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K952021

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
Combination Product No
PCCP Authorized No
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.

BZR Device Classification - Class 2, Special Controls

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 29
Devices cleared under the same product code (BZR) and FDA review panel - the closest regulatory comparables to K952021.
BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER
K973646 · Bird Products Corp. · May 1998
AIR ENTRAINER 900RT008
K953711 · Fisher & Paykel Electronics , Ltd. · Nov 1995
OXY/STAR LOW FLOW BLENDER
K952878 · Infrasonics Corp. · Sep 1995
MERIDIAN MEDICAL SYSTEMS HYPER INFLATION BAY SYST
K925591 · Merit Medical Systems, Inc. · Sep 1993
PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEM
K932709 · Precision Med Products, Ltd. · Jul 1993
HYPERINFLATION SYSTEM
K932557 · Life Shield Healthcare Products, Inc. · Jul 1993