Cleared Traditional

K932485 - PRECISION MED PRODUCTS, LTD. COAXIAL CIRCUITS

K932485 is an FDA 510(k) clearance for PRECISION MED PRODUCTS, manufactured by Precision Med Products, Ltd.. The device is a Class 1 Anesthesiology device with product code CAI cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K932485 · Precision Med Products, Ltd. · Anesthesiology device
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Jul 1993
Decision
50d
Days
Class 1
Risk

K932485 is an FDA 510(k) clearance for the PRECISION MED PRODUCTS, LTD. COAXIAL CIRCUITS. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Precision Med Products, Ltd. (Marrtinsville, US). The FDA issued a Cleared decision on July 13, 1993 after a review of 50 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 Precision Med Products, Ltd. devices

FDA 510(k) Submission Details - K932485

510(k) Number K932485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1993
Decision Date July 13, 1993
Days to Decision 50 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
90d faster than avg
Panel avg: 140d · This submission: 50d
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 K932485.
CUSTOM ANESTHESIA CIRCUITS
K932586 · Merit Medical Systems, Inc. · Jul 1993
COAXIAL CIRCUITS
K932587 · Merit Medical Systems, Inc. · Jul 1993
PMP, LTD. CUSTOM ANESTHESIA CIRCUITS
K932490 · 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 ANESTHESIA CIRCUITS
K932192 · Life Shield Healthcare Products, Inc. · Jul 1993