Cleared Traditional

K853571 - MEDIPART SODA LIME MP-3522 (FDA 510(k) Clearance)

Class I Anesthesiology device.

K853571 · Medipart Jerry Alexander · Anesthesiology device
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Oct 1985
Decision
64d
Days
Class 1
Risk

K853571 is an FDA 510(k) clearance for the MEDIPART SODA LIME MP-3522. Classified as Absorbent, Carbon-dioxide (product code CBL), Class I - General Controls.

Submitted by Medipart Jerry Alexander (Cary, US). The FDA issued a Cleared decision on October 29, 1985 after a review of 64 days - a notably fast clearance 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: 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 Medipart Jerry Alexander devices

Submission Details

510(k) Number K853571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1985
Decision Date October 29, 1985
Days to Decision 64 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 139d · This submission: 64d
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.