Cleared Traditional

K864116 - ANAGO ISOLATION MASK (#80-950) (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K864116 · Anago, Inc. · General Hospital
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Nov 1986
Decision
35d
Days
Class 2
Risk

K864116 is an FDA 510(k) clearance for the ANAGO ISOLATION MASK (#80-950). Classified as Chamber, Patient Isolation (product code LGM), Class II - Special Controls.

Submitted by Anago, Inc. (Fort Worth, US). The FDA issued a Cleared decision on November 25, 1986 after a review of 35 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5450 - the FDA general hospital 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 Anago, Inc. devices

Submission Details

510(k) Number K864116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1986
Decision Date November 25, 1986
Days to Decision 35 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 128d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LGM Chamber, Patient Isolation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.