Cleared Traditional

K980109 - CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS D...

K980109 is an FDA 510(k) clearance for CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS D..., manufactured by Sangstat Medical Corp.. The device is a Class 1 General Hospital device with product code KYX cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K980109 · Sangstat Medical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
218d
Days
Class 1
Risk

K980109 is an FDA 510(k) clearance for the CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER. Classified as Dispenser, Liquid Medication (product code KYX), Class I - General Controls.

Submitted by Sangstat Medical Corp. (Fremont, US). The FDA issued a Cleared decision on August 18, 1998 after a review of 218 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6430 - the FDA general hospital device framework. 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 Sangstat Medical Corp. devices

FDA 510(k) Submission Details - K980109

510(k) Number K980109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1998
Decision Date August 18, 1998
Days to Decision 218 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
89d slower than avg
Panel avg: 129d · This submission: 218d
Pathway characteristics
Predicate-based equivalence.

KYX Device Classification - Class 1, General Controls

Product Code KYX Dispenser, Liquid Medication
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6430
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.