Cleared Traditional

K843585 - BEMCO PORTABLE OXYGEN INHALATOR (FDA 510(k) Clearance)

Class I Anesthesiology device.

K843585 · Bemco, Inc. · Anesthesiology device
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Oct 1984
Decision
31d
Days
Class 1
Risk

K843585 is an FDA 510(k) clearance for the BEMCO PORTABLE OXYGEN INHALATOR. Classified as Regulator, Pressure, Gas Cylinder (product code CAN), Class I - General Controls.

Submitted by Bemco, Inc. (Chatham Ont. N7m 5j4, CA). The FDA issued a Cleared decision on October 12, 1984 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2700 - 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 Bemco, Inc. devices

Submission Details

510(k) Number K843585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1984
Decision Date October 12, 1984
Days to Decision 31 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 139d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAN Regulator, Pressure, Gas Cylinder
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.2700
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.