# K050433: Zimmer Ambulatory Pump Pain Management System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Orthopaedic Surgical Products
- Decided: Apr 13, 2005 after 50 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K896422 (1990). 19 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033039: Modification to: Accufuser, Accufuser Plus, Standard Procedure Kits, Mckinley, Inc. (2003) Summary page 1.
- K031249: Modification to Stryker Painpump, Stryker Instruments (2003) Summary page 1.

## Most influential descendants
- K052171: Zimmer Ambulatory Pump Pain Management System with Patient Control Module (2005), 1 descendant of its own
- K053226: Zimmer Ambulatory Pump Pain Management Systems  with Fenestrated Catheter and Flow Splitter (2006), 0 descendants of its own

## Indications for use
The Zimmer Ambulatory Pump Kit, Pain Management System is indicated for patients requiring continuous infusion of medications directly into an intraoperative, subcutaneous or epidural site for postoperative pain management. The system is convenient for use by ambulatory patients. It is the responsibility of the user to assure that the medication is prepared and administered in accordance with the drug manufacturer's package insert.

Source page: https://510kreport.com/device/K050433
Methodology: https://510kreport.com/methodology