# K030885: Modification to Stryker PAINPUMP2

- Pathway: 510(k) (Special)
- Applicant: Stryker Instruments
- Decided: Apr 18, 2003 after 28 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.
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. 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

## Indications for use
PainPump2 is an electromechanical pump which delivers a controlled amount of medication to the patient for the purpose of managing pain. The pump delivers medication using one or both of the following drug delivery profiles: an hourly flow rate and a bolus PCA (patient controlled anesthetic) dosing option. Routes of administration may be intraoperative, subcutaneous, or percutaneous. Dosage rates and patient lock out times are programmed into the PainPump I1 unit by the physician. The PainPump I I is contraindicated for infusion of blood and blood products, insulin, or life-supporting medication.

Source page: https://510kreport.com/device/K030885
Methodology: https://510kreport.com/methodology