Cleared Traditional

K080712 - SERIM HISENSE ULTRA 0.1, PART NUMBER 5167

K080712 is an FDA 510(k) clearance for SERIM HISENSE ULTRA 0.1, manufactured by Serim Research Corp.. The device is a Class 2 Gastroenterology & Urology device with product code MSY cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K080712 · Serim Research Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K080712

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 131d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSY Device Classification - Class 2, Special Controls

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
Devices cleared under the same product code (MSY) and FDA review panel - the closest regulatory comparables to K080712.
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K080712 · SERIM HISENSE ULTRA 0.1, PART NUMBER 5167
Download PDF FDA Summary Serim Research Corp.