Cleared Traditional

SPARK-KIT(TM) (K864509) - FDA 510(k) Clearance

K864509 · Lyphomed, Inc. · General Hospital
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Feb 1987
Decision
96d
Days
-
Risk

K864509 is an FDA 510(k) clearance for the SPARK-KIT(TM).

Submitted by Lyphomed, Inc. (Melrose Park, US). The FDA issued a Cleared decision on February 18, 1987 after a review of 96 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Lyphomed, Inc. devices

Submission Details

510(k) Number K864509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1986
Decision Date February 18, 1987
Days to Decision 96 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
33d faster than avg
Panel avg: 129d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -