Cleared Traditional

K941026 - THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR

K941026 is an FDA 510(k) clearance for THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR, manufactured by Thayer Medical Corp.. The device is a Class 1 Anesthesiology device with product code BZA cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K941026 · Thayer Medical Corp. · Anesthesiology device
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Aug 1994
Decision
167d
Days
Class 1
Risk

K941026 is an FDA 510(k) clearance for the THAYER MASK TO MOUTHPIECE ADAPTER/CONNECTOR. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Thayer Medical Corp. (Tucson, US). The FDA issued a Cleared decision on August 18, 1994 after a review of 167 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Thayer Medical Corp. devices

FDA 510(k) Submission Details - K941026

510(k) Number K941026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1994
Decision Date August 18, 1994
Days to Decision 167 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
27d slower than avg
Panel avg: 140d · This submission: 167d
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 49
Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K941026.
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
MERIDIAN MEDICAL SYSTEMS CONNECTORS & AIRWAY EXT
K925263 · Merit Medical Systems, Inc. · Feb 1993
FLEX-ELBOW
K912652 · Vital Signs, Inc. · Oct 1991
AEROVENT
K894969 · Monaghan Medical Corp. · Oct 1989