Cleared Traditional

K782163 - THE BLUE MASK

K782163 is an FDA 510(k) clearance for THE BLUE MASK, manufactured by Collectovac, Inc.. The device is a Class 1 Anesthesiology device with product code BSJ cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K782163 · Collectovac, Inc. · Anesthesiology device
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Mar 1979
Decision
70d
Days
Class 1
Risk

K782163 is an FDA 510(k) clearance for the THE BLUE MASK. Classified as Mask, Gas, Anesthetic (product code BSJ), Class I - General Controls.

Submitted by Collectovac, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 1, 1979 after a review of 70 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 - K782163

510(k) Number K782163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1978
Decision Date March 01, 1979
Days to Decision 70 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 140d · This submission: 70d
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.

K782163 · THE BLUE MASK
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