Cleared Traditional

K791512 - CONTINUOUS AMBULATORY DIALYSIS (CAPD)

K791512 is the FDA 510(k) clearance for CONTINUOUS AMBULATORY DIALYSIS (CAPD) by Norton Performance Plastics Corp.. It is a Class 2 Gastroenterology & Urology device (product code KDJ) cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K791512 · Norton Performance Plastics Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1980
Decision
201d
Days
Class 2
Risk

K791512 is an FDA 510(k) clearance for the CONTINUOUS AMBULATORY DIALYSIS (CAPD). Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by Norton Performance Plastics Corp. (Mchenry, US). The FDA issued a Cleared decision on February 6, 1980 after a review of 201 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Norton Performance Plastics Corp. devices

Submission Details

510(k) Number K791512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1979
Decision Date February 06, 1980
Days to Decision 201 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
71d slower than avg
Panel avg: 130d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDJ Set, Administration, For Peritoneal Dialysis, Disposable
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 - KDJ Set, Administration, For Peritoneal Dialysis, Disposable

All 78
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K791512.
INPERSOL CAPD BAG PORT CLAMP
K803300 · Abbott Laboratories · Jan 1981
INPERSOL-CAPD ADMINISTRATION SET
K801881 · Abbott Laboratories · Oct 1980
INPERSOL CAPD ADMIN. SET & CATHETER ADAP
K800993 · Abbott Laboratories · Aug 1980
CAPD TRANSFER SET JC9044
K792651 · Travenol Laboratories, S.A. · Feb 1980
CYCLER SETS MOD. #5C4143, 5C4144, 5C4145
K791899 · Travenol Laboratories, S.A. · Nov 1979
PERITONEAL DIALYSIS ADMIN. SET
K780082 · Physio-Control Corp. · Jan 1978