Cleared Traditional

K102188 - CYBOW READER, MODELS 300 & 720 (FDA 510(k) Clearance)

Class I Chemistry device.

K102188 · DFI Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
371d
Days
Class 1
Risk

K102188 is an FDA 510(k) clearance for the CYBOW READER, MODELS 300 & 720. Classified as Automated Urinalysis System (product code KQO), Class I - General Controls.

Submitted by DFI Co., Ltd. (Gangnam-Gu, Seoul, KR). The FDA issued a Cleared decision on August 9, 2011 after a review of 371 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2900 - the FDA in vitro diagnostics and chemistry 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all DFI Co., Ltd. devices

Submission Details

510(k) Number K102188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2010
Decision Date August 09, 2011
Days to Decision 371 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
283d slower than avg
Panel avg: 88d · This submission: 371d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KQO Automated Urinalysis System
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2900
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.