Cleared Traditional

DEXIDE DISPOSABLE PREP STICK W/IODOPHOR (K792270) - FDA 510(k) Clearance

K792270 · Dexide, Inc. · General Hospital
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Feb 1980
Decision
87d
Days
-
Risk

K792270 is an FDA 510(k) clearance for the DEXIDE DISPOSABLE PREP STICK W/IODOPHOR.

Submitted by Dexide, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 8, 1980 after a review of 87 days - a notably fast clearance cycle.

This device falls under the General Hospital 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.

View all Dexide, Inc. devices

Submission Details

510(k) Number K792270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1979
Decision Date February 08, 1980
Days to Decision 87 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 129d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -