Cleared Traditional

K932557 - HYPERINFLATION SYSTEM

K932557 is the FDA 510(k) clearance for HYPERINFLATION SYSTEM by Life Shield Healthcare Products, Inc.. It is a Class 2 Anesthesiology device (product code BZR) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K932557 · Life Shield Healthcare Products, Inc. · Anesthesiology device
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Jul 1993
Decision
56d
Days
Class 2
Risk

K932557 is an FDA 510(k) clearance for the HYPERINFLATION SYSTEM. Classified as Mixer, Breathing Gases, Anesthesia Inhalation (product code BZR), Class II - Special Controls.

Submitted by Life Shield Healthcare Products, Inc. (Noblesville, US). The FDA issued a Cleared decision on July 22, 1993 after a review of 56 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 Life Shield Healthcare Products, Inc. devices

Submission Details

510(k) Number K932557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1993
Decision Date July 22, 1993
Days to Decision 56 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
84d faster than avg
Panel avg: 140d · This submission: 56d
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 K932557.
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