Cleared Traditional

K944534 - PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS

K944534 is an FDA 510(k) clearance for PRIMA, manufactured by Prima, Inc.. The device is a Class 1 Anesthesiology device with product code BZA cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K944534 · Prima, Inc. · Anesthesiology device
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Nov 1994
Decision
75d
Days
Class 1
Risk

K944534 is an FDA 510(k) clearance for the PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS. Classified as Connector, Airway (extension) (product code BZA), 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 868.5810 - 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 - K944534

510(k) Number K944534 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 140d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

BZA Device Classification - Class 1, General Controls

Product Code BZA Connector, Airway (extension)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5810
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 - BZA Connector, Airway (extension)

All 57
Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K944534.
SURELOC CIRCUIT CONNECTOR
K954383 · Polamedco, Inc. · Dec 1995
PRIMA, INC. VENTILATOR HOSES
K944532 · Prima, Inc. · Dec 1994
PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS
K944535 · Prima, Inc. · Nov 1994
AIRWAY CONNECTOR WITH FLEX TUBE
K942392 · Mallinckrodt Medical · Aug 1994
MAG CONNECTORS AND AIRWAY EXTENSIONS
K931800 · Mag, Inc. · May 1993
CONNECTORS AND AIRWAY EXTENSIONS
K931036 · Life Shield Healthcare Products, Inc. · Apr 1993