Cleared Traditional

K932192 - PEDIATRIC ANESTHESIA CIRCUITS

K932192 is an FDA 510(k) clearance for PEDIATRIC ANESTHESIA CIRCUITS, manufactured by Life Shield Healthcare Products, Inc.. The device is a Class 1 Anesthesiology device with product code CAI cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K932192 · Life Shield Healthcare Products, Inc. · Anesthesiology device
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Jul 1993
Decision
57d
Days
Class 1
Risk

K932192 is an FDA 510(k) clearance for the PEDIATRIC ANESTHESIA CIRCUITS. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Life Shield Healthcare Products, Inc. (Noblesville, US). The FDA issued a Cleared decision on July 2, 1993 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5240 - 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 - K932192

510(k) Number K932192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1993
Decision Date July 02, 1993
Days to Decision 57 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
83d faster than avg
Panel avg: 140d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

CAI Device Classification - Class 1, General Controls

Product Code CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5240
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 - CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)

All 116
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K932192.
PRECISION MED PRODUCTS, LTD. COAXIAL CIRCUITS
K932485 · Precision Med Products, Ltd. · Jul 1993
PMP, LTD. PEDIATRIC ANESTHESIA CIRCUITS
K932487 · Precision Med Products, Ltd. · Jul 1993
ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS
K932190 · Life Shield Healthcare Products, Inc. · Jul 1993
PEDIATRIC TEMPERATURE MONITORING CIRCUITS
K932193 · Life Shield Healthcare Products, Inc. · Jul 1993
PEDIATRIC GASSAMPLING CIRCUITS
K932194 · Life Shield Healthcare Products, Inc. · Jul 1993
ADULT GAS SAMPLING CIRCUITS
K932195 · Life Shield Healthcare Products, Inc. · Jul 1993