Cleared Traditional

STERILE EMPTY GLASS VIALS (K883686) - FDA 510(k) Clearance

K883686 · Farris Laboratories, Inc. · General Hospital
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Sep 1988
Decision
25d
Days
-
Risk

K883686 is an FDA 510(k) clearance for the STERILE EMPTY GLASS VIALS.

Submitted by Farris Laboratories, Inc. (Desoto, US). The FDA issued a Cleared decision on September 23, 1988 after a review of 25 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 Farris Laboratories, Inc. devices

Submission Details

510(k) Number K883686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1988
Decision Date September 23, 1988
Days to Decision 25 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
104d faster than avg
Panel avg: 129d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDH
Device Class -