Cleared Traditional

K921803 - SOFNOLIME CARBON DIOXIDE ABSORBENT (FDA 510(k) Clearance)

Class I Anesthesiology device.

K921803 · Molecular Products , Ltd. · Anesthesiology device
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Oct 1992
Decision
183d
Days
Class 1
Risk

K921803 is an FDA 510(k) clearance for the SOFNOLIME CARBON DIOXIDE ABSORBENT. Classified as Absorbent, Carbon-dioxide (product code CBL), Class I - General Controls.

Submitted by Molecular Products , Ltd. (Thaxted, Essex, GB). The FDA issued a Cleared decision on October 15, 1992 after a review of 183 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5300 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Molecular Products , Ltd. devices

Submission Details

510(k) Number K921803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1992
Decision Date October 15, 1992
Days to Decision 183 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 139d · This submission: 183d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CBL Absorbent, Carbon-dioxide
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5300
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.