Cleared Traditional

CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER (K980109) - FDA 510(k) Clearance

Class I General Hospital device.

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

Submission Details

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.

Device Classification

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.