# K042405: PAINPUMP1; PAINPUMP2 - Pathway: 510(k) (Traditional) - Applicant: Stryker Corp. - Decided: Oct 14, 2004 after 41 days - Product code: FRN (Pump, Infusion) - Device class: 2 - Regulation: 21 CFR 880.5725 - Recalls of this device: 70 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 1 generation back to K030661 (2003). 3 ancestors in all. 3 later devices descend from it; 2 cite it directly. 0 of 7 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K031249: Modification to Stryker Painpump, Stryker Instruments (2003) Summary page 1. - K030661: Stryker PAINPUMP2, Stryker Instruments (2003) Summary page 1. - K040337: I-Flow Elastomeric Pump (on-Q, Painbuster, C-Bloc, Homepump), I-Flow Corp. (2004) Summary page 1. ## Most influential descendants - 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 - 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-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-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 - 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 - 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-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-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-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. - 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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. ## Indications for use PainPump1 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 intraoperatively and postoperatively through intramuscular or subcutaneous routes. PainPumpl 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. PainPumpi 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. 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 intraoperatively and postoperatively 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. 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/K042405 Methodology: https://510kreport.com/methodology