Cleared Traditional

K894906 - ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER (FDA 510(k) Clearance)

Class I Anesthesiology device.

K894906 · Med-Tek Corp. · Anesthesiology device
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Sep 1989
Decision
48d
Days
Class 1
Risk

K894906 is an FDA 510(k) clearance for the ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER. Classified as Bag, Reservoir (product code BTC), Class I - General Controls.

Submitted by Med-Tek Corp. (Glendale, US). The FDA issued a Cleared decision on September 18, 1989 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5320 - 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.

View all Med-Tek Corp. devices

Submission Details

510(k) Number K894906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1989
Decision Date September 18, 1989
Days to Decision 48 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 139d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BTC Bag, Reservoir
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5320
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.