Cleared Traditional

BARBITAL BUFFER (K771721) - FDA 510(k) Clearance

K771721 · Sigma Chemical Co. · Chemistry device
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Oct 1977
Decision
35d
Days
-
Risk

K771721 is an FDA 510(k) clearance for the BARBITAL BUFFER.

Submitted by Sigma Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on October 18, 1977 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel. 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.

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Submission Details

510(k) Number K771721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1977
Decision Date October 18, 1977
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 88d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -