Cleared Traditional

K944533 - PRIMA

K944533 is the FDA 510(k) clearance for PRIMA by Prima, Inc.. It is a Class 1 Anesthesiology device (product code CAI) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K944533 · Prima, Inc. · Anesthesiology device
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Nov 1994
Decision
75d
Days
Class 1
Risk

K944533 is an FDA 510(k) clearance for the PRIMA, INC. ADULT ANESTHESIA CIRCUIT. 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 November 29, 1994 after a review of 75 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

Submission Details

510(k) Number K944533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1994
Decision Date November 29, 1994
Days to Decision 75 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
65d faster than avg
Panel avg: 140d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 25
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K944533.
KARL STORZ LARYNGOSCOPE ACCESSORIES
K944295 · KARL STORZ Endoscopy-America, Inc. · Oct 1994
PEDIATRIC GAS SAMPLING CIRCUITS
K932589 · Merit Medical Systems, Inc. · Jul 1993
ADULT GAS SAMPLING CIRCUITS
K932590 · Merit Medical Systems, Inc. · Jul 1993
ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS
K932583 · Merit Medical Systems, Inc. · Jul 1993
PEDIATRIC TEMPERATURE MONITORING CIRCUITS
K932588 · Merit Medical Systems, Inc. · Jul 1993
PEDIATRIC ANESTHESIA CIRCUITS
K932585 · Merit Medical Systems, Inc. · Jul 1993