Cleared Traditional

K041636 - H&S-CONDUCTIVITY STANDARD SOLUTION

K041636 is an FDA 510(k) clearance for H&S-CONDUCTIVITY STANDARD SOLUTION, manufactured by H & S Technical Services. The device is a Class 2 Gastroenterology & Urology device with product code FKH cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K041636 · H & S Technical Services · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
15d
Days
Class 2
Risk

K041636 is an FDA 510(k) clearance for the H&S-CONDUCTIVITY STANDARD SOLUTION. Classified as Solution-test Standard-conductivity, Dialysis (product code FKH), Class II - Special Controls.

Submitted by H & S Technical Services (Mesa, US). The FDA issued a Cleared decision on July 2, 2004 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 H & S Technical Services devices

FDA 510(k) Submission Details - K041636

510(k) Number K041636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2004
Decision Date July 02, 2004
Days to Decision 15 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 130d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FKH Device Classification - Class 2, Special Controls

Product Code FKH Solution-test Standard-conductivity, Dialysis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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.