Cleared Traditional

SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 (K080712) - FDA 510(k) Clearance

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

K080712 · Serim Research Corp. · Gastroenterology & Urology device
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May 2008
Decision
54d
Days
Class 2
Risk

K080712 is an FDA 510(k) clearance for the SERIM HISENSE ULTRA 0.1, PART NUMBER 5167. Classified as Strip, Test, Reagent, Residuals For Dialysate, Disinfectant (product code MSY), Class II - Special Controls.

Submitted by Serim Research Corp. (Elkhart, US). The FDA issued a Cleared decision on May 6, 2008 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5665 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Serim Research Corp. devices

Submission Details

510(k) Number K080712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2008
Decision Date May 06, 2008
Days to Decision 54 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
76d faster than avg
Panel avg: 130d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5665
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.

Regulatory Peers - MSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant

All 12
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