Cleared Traditional

K093479 - DISPOSABLE SUCTION AND IRRIGATION SYSTEM

K093479 is an FDA 510(k) clearance for DISPOSABLE SUCTION AND IRRIGATION SYSTEM, manufactured by Modern Medical Equipment Mfg., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FHF cleared through the Traditional 510(k) pathway after a 191-day FDA review.

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

FDA 510(k) Submission Details - K093479

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.

FHF Device Classification - Class 2, Special Controls

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.