Cleared Traditional

K974387 - PDM3 DISINFECTION SYSTEM FOR PERITONEAL...

K974387 is an FDA 510(k) clearance for PDM3 DISINFECTION SYSTEM FOR PERITONEAL..., manufactured by Microwave Medical Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDJ cleared through the Traditional 510(k) pathway after a 649-day FDA review.

K974387 · Microwave Medical Systems, Inc. · Gastroenterology & Urology device
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Sep 1999
Decision
649d
Days
Class 2
Risk

K974387 is an FDA 510(k) clearance for the PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER .... Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by Microwave Medical Systems, Inc. (Acton, US). The FDA issued a Cleared decision on September 1, 1999 after a review of 649 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Microwave Medical Systems, Inc. devices

FDA 510(k) Submission Details - K974387

510(k) Number K974387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1997
Decision Date September 01, 1999
Days to Decision 649 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
519d slower than avg
Panel avg: 130d · This submission: 649d
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 94
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K974387.
FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211
K041792 · Fresenius Medical Care North America · Sep 2004
HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q
K031676 · Baxter Healthcare Corp · Nov 2003
FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR
K022412 · Fresenius Medical Care North America · Mar 2003
HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE
K972579 · Baxter Healthcare Corp · Oct 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