Cleared Traditional

K761222 - BENZOIN ISOBUTYL ETHER (FDA 510(k) Clearance)

K761222 · Solar Laboratories, Inc. · Orthopedic device
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Dec 1976
Decision
9d
Days
-
Risk

K761222 is an FDA 510(k) clearance for the BENZOIN ISOBUTYL ETHER.

Submitted by Solar Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 16, 1976 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Orthopedic 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 K761222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1976
Decision Date December 16, 1976
Days to Decision 9 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 122d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -