Cleared Traditional

DISPOSABLE SUCTION AND IRRIGATION SYSTEM (K093479) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K093479 · Modern Medical Equipment Mfg., Ltd. · Gastroenterology & Urology device
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May 2010
Decision
191d
Days
Class 2
Risk

K093479 is an FDA 510(k) clearance for the DISPOSABLE SUCTION AND IRRIGATION SYSTEM. Classified as System, Evacuator, Fluid (product code FHF), Class II - Special Controls.

Submitted by Modern Medical Equipment Mfg., Ltd. (Heng Li, Dongguan, Guangdong, CN). The FDA issued a Cleared decision on May 19, 2010 after a review of 191 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4370 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Modern Medical Equipment Mfg., Ltd. devices

Submission Details

510(k) Number K093479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2009
Decision Date May 19, 2010
Days to Decision 191 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 130d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FHF System, Evacuator, Fluid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4370
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.