# K031249: Modification to Stryker Painpump

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Jul 21, 2003 after 94 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
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Infusion pump system marketed by Stryker: named in the summary without a submission number
- (no number) Infusion pump system marketed by I-Flow Corporation: named in the summary without a submission number
- (no number) Infusion pump system marketed by Sgarlato: named in the summary without a submission number
- (no number) Catheter marketed by Stryker: named in the summary without a submission number
- (no number) Catheter marketed by I-Flow: named in the summary without a submission number
- (no number) Catheter marketed by Sims Porter: named in the summary without a submission number

## Most influential descendants
- K042405: PAINPUMP1; PAINPUMP2 (2004), 3 descendants of its own
- K050433: Zimmer Ambulatory Pump Pain Management System (2005), 2 descendants of its own
- K052171: Zimmer Ambulatory Pump Pain Management System with Patient Control Module (2005), 1 descendant of its own
- K043466: PAINPUMP2 (2005), 1 descendant of its own
- K072702: Stryker Antimic Catheter (2008), 0 descendants of its own

## Indications for use
The Stryker PainPump delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. The pump infuses the medication at an hourly flow rate. Medications are infused through intramuscular or subcutaneous routes, The Stryker PainPurnp is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous.

Source page: https://510kreport.com/device/K031249
Methodology: https://510kreport.com/methodology