Cleared Traditional

K791512 - CONTINUOUS AMBULATORY DIALYSIS (CAPD)

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

K791512 · Norton Performance Plastics Corp. · Gastroenterology & Urology device
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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

FDA 510(k) Submission Details - K791512

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
70d slower than avg
Panel avg: 131d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDJ Device Classification - Class 2, Special Controls

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 100
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K791512.
INPERSOL CAPD ADMIN. SET & CATHETER ADAP
K800993 · Abbott Laboratories · Aug 1980
CLIRANS TE15 HOLLOW FIBER DIALYZER
K801193 · Terumo America, Inc. · Aug 1980
PERITONEAL DIALYSIS CYCLER SET W/PUMP
K801220 · American Medical Products, Inc. · Aug 1980
CAPD TRANSFER SET JC9044
K792651 · Travenol Laboratories, S.A. · Feb 1980
DISPOSABLE PERITONEAL DIALYSIS EXTENSION
K791722 · American Medical Products, Inc. · Nov 1979
CYCLER SETS MOD. #5C4143, 5C4144, 5C4145
K791899 · Travenol Laboratories, S.A. · Nov 1979