Cleared Traditional

K852405 - LASERSAFE PERSONNEL AND PATIENT SHIELDS (FDA 510(k) Clearance)

Class I Anesthesiology device.

K852405 · Lasersafe, Inc. · Anesthesiology device
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Oct 1985
Decision
117d
Days
Class 1
Risk

K852405 is an FDA 510(k) clearance for the LASERSAFE PERSONNEL AND PATIENT SHIELDS. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Lasersafe, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on October 1, 1985 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5240 - 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 Lasersafe, Inc. devices

Submission Details

510(k) Number K852405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1985
Decision Date October 01, 1985
Days to Decision 117 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 139d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5240
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.