Cleared Traditional

K963668 - MEDISYSTEMS PERITONEAL DIALYSIS SETS

K963668 is an FDA 510(k) clearance for MEDISYSTEMS PERITONEAL DIALYSIS SETS, manufactured by Medisystems Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KDJ cleared through the Traditional 510(k) pathway after a 336-day FDA review.

K963668 · Medisystems Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
336d
Days
Class 2
Risk

K963668 is an FDA 510(k) clearance for the MEDISYSTEMS PERITONEAL DIALYSIS SETS. Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by Medisystems Corp. (Washington, US). The FDA issued a Cleared decision on August 15, 1997 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Medisystems Corp. devices

FDA 510(k) Submission Details - K963668

510(k) Number K963668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1996
Decision Date August 15, 1997
Days to Decision 336 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
205d slower than avg
Panel avg: 131d · This submission: 336d
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 K963668.
PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE
K974387 · Microwave Medical Systems, Inc. · Sep 1999
HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE
K972579 · Baxter Healthcare Corp · Oct 1997
NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET
K972731 · Klein-Baker Medical, Inc. · Sep 1997
ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493
K961825 · Baxter Healthcare Corp · Aug 1996
RAPID DISCONNECT Y-SET, CAT. NO. 48-7000
K930843 · National Medical Care, Medical Products Div., Inc. · Aug 1994
ABBOTT SMART CAP
K921818 · Abbott Laboratories · Mar 1994