Cleared Traditional

K931345 - CONNECTORS AND AIRWAY EXTENSIONS

K931345 is an FDA 510(k) clearance for CONNECTORS AND AIRWAY EXTENSIONS, manufactured by Precision Med Products, Ltd.. The device is a Class 1 Anesthesiology device with product code BZA cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K931345 · Precision Med Products, Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
37d
Days
Class 1
Risk

K931345 is an FDA 510(k) clearance for the CONNECTORS AND AIRWAY EXTENSIONS. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Precision Med Products, Ltd. (Marrtinsville, US). The FDA issued a Cleared decision on April 23, 1993 after a review of 37 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 Precision Med Products, Ltd. devices

FDA 510(k) Submission Details - K931345

510(k) Number K931345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1993
Decision Date April 23, 1993
Days to Decision 37 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
103d faster than avg
Panel avg: 140d · This submission: 37d
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 58
Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K931345.
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
MERIDIAN MEDICAL SYSTEMS CONNECTORS & AIRWAY EXT
K925263 · Merit Medical Systems, Inc. · Feb 1993