Cleared Traditional

K953788 - UNICOR, INC. GAS SAMPLING LINES & CONNECTORS

K953788 is an FDA 510(k) clearance for UNICOR, manufactured by Unicor, Inc.. The device is a Class 1 Anesthesiology device with product code CAI cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K953788 · Unicor, Inc. · Anesthesiology device
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Sep 1995
Decision
36d
Days
Class 1
Risk

K953788 is an FDA 510(k) clearance for the UNICOR, INC. GAS SAMPLING LINES & CONNECTORS. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Unicor, Inc. (Cleveland, US). The FDA issued a Cleared decision on September 19, 1995 after a review of 36 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 Unicor, Inc. devices

FDA 510(k) Submission Details - K953788

510(k) Number K953788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1995
Decision Date September 19, 1995
Days to Decision 36 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
104d faster than avg
Panel avg: 140d · This submission: 36d
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 117
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K953788.
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K952014 · Prima, Inc. · May 1995
PRIMA PEDIATRIC GAS SAMPLING CIRCUITS
K952016 · Prima, Inc. · May 1995
PRIMA MAPLESON D CIRCUIT
K952017 · Prima, Inc. · May 1995
PRIMA COAXIAL CIRCUITS
K952018 · Prima, Inc. · May 1995
PRIMA ADULT GAS SAMPLING CIRCUITS
K952019 · Prima, Inc. · May 1995
PRIMA PEDIATRIC ANESTHESIA CIRCUITS
K952020 · Prima, Inc. · May 1995