Cleared Traditional

K821395 - SADDLEBAG INSTRUMENT PAD W/POUCHES (FDA 510(k) Clearance)

K821395 · Kleen Test Products · General Hospital
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Jun 1982
Decision
23d
Days
-
Risk

K821395 is an FDA 510(k) clearance for the SADDLEBAG INSTRUMENT PAD W/POUCHES.

Submitted by Kleen Test Products (Mchenry, US). The FDA issued a Cleared decision on June 3, 1982 after a review of 23 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.

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Submission Details

510(k) Number K821395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1982
Decision Date June 03, 1982
Days to Decision 23 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
105d faster than avg
Panel avg: 128d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -