Cleared Traditional

K870472 - ACUTE PERITONEAL DIALYSIS KIT

K870472 is an FDA 510(k) clearance for ACUTE PERITONEAL DIALYSIS KIT, manufactured by Quinton, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FKO cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K870472 · Quinton, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1987
Decision
22d
Days
Class 2
Risk

K870472 is an FDA 510(k) clearance for the ACUTE PERITONEAL DIALYSIS KIT. Classified as Catheter, Peritoneal Dialysis, Single Use (product code FKO), Class II - Special Controls.

Submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on February 25, 1987 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - 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 Quinton, Inc. devices

FDA 510(k) Submission Details - K870472

510(k) Number K870472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1987
Decision Date February 25, 1987
Days to Decision 22 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
109d faster than avg
Panel avg: 131d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FKO Device Classification - Class 2, Special Controls

Product Code FKO Catheter, Peritoneal Dialysis, Single Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
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 - FKO Catheter, Peritoneal Dialysis, Single Use

All 12
Devices cleared under the same product code (FKO) and FDA review panel - the closest regulatory comparables to K870472.
PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM)
K874650 · Quinton, Inc. · Dec 1987
DIALY-NATE SET & DIALY-NATE CATHETER
K872221 · Gesco Intl., Inc. · Oct 1987
MODIFIED USE OF PULL-APART INTRODUCER SET
K871730 · Quinton, Inc. · May 1987
PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8
K860155 · Medical Components, Inc. · Feb 1986
CAPD STAGED CONNECTOR
K845041 · Abbott Laboratories · Feb 1985
LAZARUS-NELSON PERITONEAL LAVAGE TRAY
K813336 · American Pharmaseal Div. Ahsc · Dec 1981