Cleared Traditional

K932560 - VOLUME VENTILATORS

K932560 is an FDA 510(k) clearance for VOLUME VENTILATORS, manufactured by Life Shield Healthcare Products, Inc.. The device is a Class 1 Anesthesiology device with product code BZO cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K932560 · Life Shield Healthcare Products, Inc. · Anesthesiology device
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Jul 1993
Decision
56d
Days
Class 1
Risk

K932560 is an FDA 510(k) clearance for the VOLUME VENTILATORS. Classified as Set, Tubing And Support, Ventilator (w Harness) (product code BZO), Class I - General 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 868.5975 - 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

FDA 510(k) Submission Details - K932560

510(k) Number K932560 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 140d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

BZO Device Classification - Class 1, General Controls

Product Code BZO Set, Tubing And Support, Ventilator (w Harness)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5975
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BZO Set, Tubing And Support, Ventilator (w Harness)

All 52
Devices cleared under the same product code (BZO) and FDA review panel - the closest regulatory comparables to K932560.
TUBE, INHALER OXYGEN
K935582 · Puritas Health Care, Inc. · Jan 1994
STAR BREATHING CIRCUITS
K934753 · Infrasonics Corp. · Oct 1993
PRECISION MED PRODUCTS LTD. VENTILATOR HOSE
K932706 · Precision Med Products, Ltd. · Jul 1993
PRECISION MED PRODUCTS LTD VOLUME VENTILATORS
K932712 · Precision Med Products, Ltd. · Jul 1993
VENTILATOR HOSES
K932563 · Life Shield Healthcare Products, Inc. · Jul 1993
DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED
K922479 · Intertech Resources, Inc. · Oct 1992