Cleared Traditional

K182443 - Pristine Hemodialysis Catheter (FDA 510(k) Clearance)

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

K182443 · Pristine Access Technologies , Ltd. · Gastroenterology & Urology device
May 2019
Decision
266d
Days
Class 2
Risk

K182443 is an FDA 510(k) clearance for the Pristine Hemodialysis Catheter. This device is classified as a Catheter, Hemodialysis, Implanted (Class II - Special Controls, product code MSD).

Submitted by Pristine Access Technologies , Ltd. (Tel-Aviv, IL). The FDA issued a Cleared decision on May 31, 2019, 266 days after receiving the submission on September 7, 2018.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.

Submission Details

510(k) Number K182443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2018
Decision Date May 31, 2019
Days to Decision 266 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 156d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MSD Catheter, Hemodialysis, Implanted
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.