Cleared Traditional

K925263 - MERIDIAN MEDICAL SYSTEMS CONNECTORS & A...

K925263 is an FDA 510(k) clearance for MERIDIAN MEDICAL SYSTEMS CONNECTORS & A..., manufactured by Merit Medical Systems, Inc.. The device is a Class 1 Anesthesiology device with product code BZA cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K925263 · Merit Medical Systems, Inc. · Anesthesiology device
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Feb 1993
Decision
106d
Days
Class 1
Risk

K925263 is an FDA 510(k) clearance for the MERIDIAN MEDICAL SYSTEMS CONNECTORS & AIRWAY EXT. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Merit Medical Systems, Inc. (Indianapolis, US). The FDA issued a Cleared decision on February 2, 1993 after a review of 106 days - within the typical 510(k) review window.

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 Merit Medical Systems, Inc. devices

FDA 510(k) Submission Details - K925263

510(k) Number K925263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1992
Decision Date February 02, 1993
Days to Decision 106 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
34d faster than avg
Panel avg: 140d · This submission: 106d
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 35
Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K925263.
AIRWAY CONNECTOR WITH FLEX TUBE
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AEROVENT
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K881230 · Intertech Resources, Inc. · Apr 1988