Cleared Traditional

K940544 - DOUBLE TRACH SEIVEL CONNECTOR

K940544 is an FDA 510(k) clearance for DOUBLE TRACH SEIVEL CONNECTOR, manufactured by Fvtnks. The device is a Class 1 Anesthesiology device with product code BZA cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K940544 · Fvtnks · Anesthesiology device
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Apr 1994
Decision
71d
Days
Class 1
Risk

K940544 is an FDA 510(k) clearance for the DOUBLE TRACH SEIVEL CONNECTOR. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Fvtnks (Indianapolis, US). The FDA issued a Cleared decision on April 19, 1994 after a review of 71 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 Fvtnks devices

FDA 510(k) Submission Details - K940544

510(k) Number K940544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1994
Decision Date April 19, 1994
Days to Decision 71 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
69d faster than avg
Panel avg: 140d · This submission: 71d
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 59
Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K940544.
PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS
K944534 · Prima, Inc. · Nov 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
CONNECTORS AND AIRWAY EXTENSIONS
K931038 · Med-Plastics Intl., Inc. · Apr 1993