Cleared Traditional

K952016 - PRIMA PEDIATRIC GAS SAMPLING CIRCUITS

K952016 is an FDA 510(k) clearance for PRIMA PEDIATRIC GAS SAMPLING CIRCUITS, manufactured by Prima, Inc.. The device is a Class 1 Anesthesiology device with product code CAI cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K952016 · Prima, Inc. · Anesthesiology device
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May 1995
Decision
24d
Days
Class 1
Risk

K952016 is an FDA 510(k) clearance for the PRIMA PEDIATRIC GAS SAMPLING CIRCUITS. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Prima, Inc. (Cleveland, US). The FDA issued a Cleared decision on May 22, 1995 after a review of 24 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 Prima, Inc. devices

FDA 510(k) Submission Details - K952016

510(k) Number K952016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1995
Decision Date May 22, 1995
Days to Decision 24 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
116d faster than avg
Panel avg: 140d · This submission: 24d
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 K952016.
PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS
K952014 · 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
PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS
K952009 · Prima, Inc. · May 1995