Cleared Traditional

K852405 - LASERSAFE PERSONNEL AND PATIENT SHIELDS

K852405 is an FDA 510(k) clearance for LASERSAFE PERSONNEL AND PATIENT SHIELDS, manufactured by Lasersafe, Inc.. The device is a Class 1 Anesthesiology device with product code CAI cleared through the Traditional 510(k) pathway after a 117-day FDA review.

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

FDA 510(k) Submission Details - K852405

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
23d faster than avg
Panel avg: 140d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

CAI Device Classification - Class 1, General Controls

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.

Regulatory Peers - CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)

All 117
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K852405.
CIRCUIT, ANES. BREATHING (NON-REBREATHING)
K861438 · Vital Signs, Inc. · May 1986
GAS/PRES MONIT ENDOT TUB CONN/ADOP W/ & W/O TUB
K852632 · Medicomp, Inc. · Jan 1986
HYDRO-BAC FILTER
K852866 · Medicomp, Inc. · Jan 1986
AMBU RUBEN CIRCLE ANESTHESIA SYSTEM
K844149 · Ambu, Inc. · Nov 1984
SAMSON 1000 ANESTHESIA CIRCUIT
K842488 · J. H. Emerson Co. · Jul 1984
BABYSET TM & PAC TM -PULMONARY ASSIST
K841264 · Life Design Systems, Inc. · Jun 1984