Cleared Traditional

K811260 - BARALYME CO2 ABSORBENT (FDA 510(k) Clearance)

Class I Chemistry device.

K811260 · Allied Healthcare Products, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1981
Decision
21d
Days
Class 1
Risk

K811260 is an FDA 510(k) clearance for the BARALYME CO2 ABSORBENT. Classified as Absorbent, Carbon-dioxide (product code CBL), Class I - General Controls.

Submitted by Allied Healthcare Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 27, 1981 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 868.5300 - the FDA in vitro diagnostics and chemistry 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 Allied Healthcare Products, Inc. devices

Submission Details

510(k) Number K811260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1981
Decision Date May 27, 1981
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 88d · This submission: 21d
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.