Cleared Traditional

K953506 - WESTMED RESPIRATORY LUER ADAPTOR

K953506 is an FDA 510(k) clearance for WESTMED RESPIRATORY LUER ADAPTOR, manufactured by Westmed Intl.. The device is a Class 1 Anesthesiology device with product code BXY cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K953506 · Westmed Intl. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
51d
Days
Class 1
Risk

K953506 is an FDA 510(k) clearance for the WESTMED RESPIRATORY LUER ADAPTOR. Classified as Flowmeter, Calibration, Gas (product code BXY), Class I - General Controls.

Submitted by Westmed Intl. (Tucson, US). The FDA issued a Cleared decision on September 15, 1995 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2350 - 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 Westmed Intl. devices

FDA 510(k) Submission Details - K953506

510(k) Number K953506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1995
Decision Date September 15, 1995
Days to Decision 51 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 140d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

BXY Device Classification - Class 1, General Controls

Product Code BXY Flowmeter, Calibration, Gas
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.2350
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 - BXY Flowmeter, Calibration, Gas

Devices cleared under the same product code (BXY) and FDA review panel - the closest regulatory comparables to K953506.
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