Cleared Traditional

K860686 - FACEGLOV,ANESTHETIC GAS MASK

K860686 is an FDA 510(k) clearance for FACEGLOV, manufactured by Loran , Ltd.. The device is a Class 1 Anesthesiology device with product code BSJ cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K860686 · Loran , Ltd. · Anesthesiology device
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Apr 1986
Decision
64d
Days
Class 1
Risk

K860686 is an FDA 510(k) clearance for the FACEGLOV,ANESTHETIC GAS MASK. Classified as Mask, Gas, Anesthetic (product code BSJ), Class I - General Controls.

Submitted by Loran , Ltd. (Aurora, US). The FDA issued a Cleared decision on April 30, 1986 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5550 - 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.

FDA 510(k) Submission Details - K860686

510(k) Number K860686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1986
Decision Date April 30, 1986
Days to Decision 64 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 140d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

BSJ Device Classification - Class 1, General Controls

Product Code BSJ Mask, Gas, Anesthetic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5550
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 - BSJ Mask, Gas, Anesthetic

All 38
Devices cleared under the same product code (BSJ) and FDA review panel - the closest regulatory comparables to K860686.
MP-XML DISPOSABLE FACE MASK
K862782 · Medipart Jerry Alexander · Aug 1986
MP-XMV DISPOSABLE FACE MASK
K862783 · Medipart Jerry Alexander · Aug 1986
MP-XMO DISPOSABLE FACE MASK
K862784 · Medipart Jerry Alexander · Aug 1986
MEDIPART FACE MASK & FILTER MP-30XM
K844493 · Medipart Jerry Alexander · Dec 1984
MEDIPART FACE MASK MP-XM
K844494 · Medipart Jerry Alexander · Dec 1984
CUSHION-FLEX TM
K843169 · Life Design Systems, Inc. · Aug 1984
K860686 · FACEGLOV,ANESTHETIC GAS MASK
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