# K043466: PAINPUMP2

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: May 10, 2005 after 146 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 72 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K030661 (2003). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042405: PAINPUMP1; PAINPUMP2, Stryker Corp. (2004) Summary page 1.
- K040337: I-Flow Elastomeric Pump (on-Q, Painbuster, C-Bloc, Homepump), I-Flow Corp. (2004) Summary page 1.

## Most influential descendants
- K072702: Stryker Antimic Catheter (2008), 0 descendants of its own

## Recalls of this device
- Sep 2, 2010 · Not classified · Z-2593-2010: All of the failures lead to the patient receiving less medication than intended. Certain lots of the pain pump have a high failure rate associated with a cracked port housing which leads to internal o
- Sep 2, 2010 · Not classified · Z-2592-2010: All of the failures lead to the patient receiving less medication than intended. Certain lots of the pain pump have a high failure rate associated with a cracked port housing which leads to internal o
- Sep 2, 2010 · Not classified · Z-2594-2010: All of the failures lead to the patient receiving less medication than intended. Certain lots of the pain pump have a high failure rate associated with a cracked port housing which leads to internal o
- Sep 2, 2010 · Not classified · Z-2591-2010: All of the failures lead to the patient receiving less medication than intended. Certain lots of the pain pump have a high failure rate associated with a cracked port housing which leads to internal o
- Aug 16, 2010 · Not classified · Z-0096-2011: The instructions for use (IFU) has been revised for health care professionals. The indication for use has been changed to remove site specific pain management. The firm has revised the warning to not 
- Jun 16, 2009 · Not classified · Z-1757-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1769-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1740-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1770-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1746-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1778-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1758-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1784-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1766-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1749-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1781-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1763-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1786-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1756-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1775-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1744-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1736-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1774-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1779-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1764-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1776-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1773-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1771-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1752-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1772-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1760-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1755-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1742-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1788-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1745-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1785-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1762-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1765-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1777-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1780-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1750-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1737-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1761-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1747-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1738-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1787-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1741-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1759-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1739-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
- Jun 16, 2009 · Not classified · Z-1743-2009: The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.

## Indications for use
The Stryker PainPump2 delivers controlled amounts of medication and narcotics directly to the intraoperative site for pain management. The pump infuses the medication at an hourly flow rate and provided the option for patient controlled bolus doses. Medications and narcotics are infused through intramuscular, subcutaneous, and epidural routes. The Stryker 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 provided the option for patient controlled bolus doses. Medications are infused through intramuscular and subcutaneous routes. The Stryker PainPump2 is intended for controlled delivery of local anesthetics and narcotics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous. The Stryker PainPump2 is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

Source page: https://510kreport.com/device/K043466
Methodology: https://510kreport.com/methodology