Cleared Traditional

K843422 - OHMEDA BAIN CIRCUIT ADAPTER GMS ABSOR (FDA 510(k) Clearance)

Class I Anesthesiology device.

K843422 · Ohmeda Medical · Anesthesiology device
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Oct 1984
Decision
53d
Days
Class 1
Risk

K843422 is an FDA 510(k) clearance for the OHMEDA BAIN CIRCUIT ADAPTER GMS ABSOR. Classified as Absorber, Carbon-dioxide (product code BSF), Class I - General Controls.

Submitted by Ohmeda Medical (Madison, US). The FDA issued a Cleared decision on October 23, 1984 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5310 - 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 Ohmeda Medical devices

Submission Details

510(k) Number K843422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1984
Decision Date October 23, 1984
Days to Decision 53 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 139d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BSF Absorber, Carbon-dioxide
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5310
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.