Cleared Traditional

K840437 - HEMASITE ACCESSORIES MODIFICATION

K840437 is the FDA 510(k) clearance for HEMASITE ACCESSORIES MODIFICATION by Renal Systems, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNZ) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K840437 · Renal Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1984
Decision
20d
Days
Class 2
Risk

K840437 is an FDA 510(k) clearance for the HEMASITE ACCESSORIES MODIFICATION. Classified as Accessories, A-v Shunt (product code KNZ), Class II - Special Controls.

Submitted by Renal Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1984 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - 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 Renal Systems, Inc. devices

Submission Details

510(k) Number K840437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1984
Decision Date February 21, 1984
Days to Decision 20 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 130d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNZ Accessories, A-v Shunt
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
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.