# K053226: Zimmer Ambulatory Pump Pain Management Systems  with Fenestrated Catheter and Flow Splitter

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Jan 31, 2006 after 75 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: 9 generations back to K896422 (1990). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050433: Zimmer Ambulatory Pump Pain Management System, Zimmer Orthopaedic Surgical Products (2005) Summary page 3.
- K052171: Zimmer Ambulatory Pump Pain Management System with Patient Control Module, Zimmer, Inc. (2005) Summary page 3.
- K033039: Modification to: Accufuser, Accufuser Plus, Standard Procedure Kits, Mckinley, Inc. (2003) Summary page 4.
- K023098: Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit, Mckinley Infuser (2002) Summary page 4.

## Indications for use
The Zimmer Pain Management System and Zimmer Pain Management System with Patient Control Module (PCM) are indicated for the slow, continuous or subcutaneous administration of pain medications. It may also include the slow, continuous infusion of pain medications directly into an intraoperative, or subcutaneous site for postoperative pain management or the continuous infusion of a local anesthetic near a nerve for regional anesthesia. The PCM allows for intermittent bolus doses of medication on patient demand. The system is convenient for use by ambulatory patients. It is the responsibility of the healthcare provider to assure that the medication is prepared and administered in accordance with the drug manufacturer's package insert.

Source page: https://510kreport.com/device/K053226
Methodology: https://510kreport.com/methodology