# K030661: Stryker PAINPUMP2

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: May 30, 2003 after 88 days
- Product code: MEA (Pump, Infusion, Pca)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 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) Existing infusion pump systems marketed by I-Flow Corporation: named in the summary without a submission number
- (no number) Existing catheters marketed by I-Flow: named in the summary without a submission number
- (no number) Existing catheters marketed by Sims Portex: named in the summary without a submission number

## Most influential descendants
- K042405: PAINPUMP1; PAINPUMP2 (2004), 3 descendants of its own
- K043466: PAINPUMP2 (2005), 1 descendant of its own
- K072702: Stryker Antimic Catheter (2008), 0 descendants of its own
- K052221: Ambit Push & Play Ambulatory Infusion Pump (2005), 0 descendants of its own

## Recalls of this device
- Feb 1, 2010 · Not classified · Z-2357-2010: Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- Feb 1, 2010 · Not classified · Z-2359-2010: Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- Feb 1, 2010 · Not classified · Z-2358-2010: Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.

## Indications for use
PainPump2 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 and provides the option for patient controlled bolus doses. Medications are infused through intramuscular or subcutaneous routes. PainPump2 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/K030661
Methodology: https://510kreport.com/methodology