# K974387: PDM3 Disinfection System for Peritoneal Dialysis Exchanges, Patient Transfer Set PTS102, Cap, High Temperature

- Pathway: 510(k) (Traditional)
- Applicant: Microwave Medical Systems, Inc.
- Decided: Sep 1, 1999 after 649 days
- Product code: KDJ (Set, Administration, For Peritoneal Dialysis, Disposable)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The PDM3 is intended for use by Peritoneal Dialysis patients in moist-heat intraluminal disinfection of ONLY the MMS PTS102 Patient Transfer Set connector when mated with a Baxte UltraBag™ connector or with a MMS 190259 High Temperature Cap. The MMS PTS102 Transfer Set is intended for use by Peritoneal Dialysis Patients to connect between the patient’s catheter and either: 1) a Baxter UltraBag™ dialysate solution bag connector during a Peritoneal Dialysis Solution Exchange process, or 2) a MMS High Temperature Cap (Model 190259) when the bag connector is removed.

Source page: https://510kreport.com/device/K974387
Methodology: https://510kreport.com/methodology