Cleared Traditional

SOLOPAK PHARMACEUTICALS INC. STERILE EMPTY VIAL (K950822) - FDA 510(k) Clearance

K950822 · Solopak Laboratories, Inc. · General Hospital
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Mar 1995
Decision
28d
Days
-
Risk

K950822 is an FDA 510(k) clearance for the SOLOPAK PHARMACEUTICALS INC. STERILE EMPTY VIAL.

Submitted by Solopak Laboratories, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on March 22, 1995 after a review of 28 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 Solopak Laboratories, Inc. devices

Submission Details

510(k) Number K950822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1995
Decision Date March 22, 1995
Days to Decision 28 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDH
Device Class -