510(k) · Cleared
Recalled · 2010PAINPUMP1; PAINPUMP2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · FRN Pump, Infusion
Cleared on Oct 14, 2004 as substantially equivalent to K031249 (Stryker Instruments, 2003) and 2 other predicates after a 41-day review. Its family tree reaches back 1 generation to 2003. 3 later devices descend from it. It has been recalled 70 times.
- Decided
- Oct 14, 2004
- Review
- 41 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 70
- Predicates
- 3
Its longest line of descent runs back 1 generation to K030661 (2003). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK030661 Stryker PAINPUMP2Stryker Instruments · 2003 · Recalled
- This deviceK042405 PAINPUMP1; PAINPUMP2Stryker Corp. · 2004
- Descendant · cites it directly · 1 of its ownK043466 PAINPUMP2Stryker Instruments · 2005 · Recalled
- Descendant · 2 generations on · 0 of its ownK072702 Stryker Antimic CatheterStryker Instruments, Instruments Div. · 2008
- Descendant · cites it directly · 0 of its ownK052221 Ambit Push & Play Ambulatory Infusion PumpSorenson Medical, Inc. · 2005 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030661 | Stryker PAINPUMP2 | Stryker Instruments | 2003 | 3 |
| 0 (this device) | K042405 | PAINPUMP1; PAINPUMP2 | Stryker Corp. | 2004 | — |
| +1 | K043466 | PAINPUMP2 | Stryker Instruments | 2005 | 72 |
| +2 | K072702 | Stryker Antimic Catheter | Stryker Instruments, Instruments Div. | 2008 | — |
| +1 | K052221 | Ambit Push & Play Ambulatory Infusion Pump | Sorenson Medical, Inc. | 2005 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FRN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031249 | Modification to Stryker PainpumpSummary page 1…Infusion Pump; Electromechanical Ambulatory Infusion Pump Classification Name: Pump, Infusion, PCA Equivalent to: K031249, Stryker PainPumpl; K030661, PainPump2, K040337; I-Flow Elastomeric Pump w… | 2003 |
| * | K030661 | Stryker PAINPUMP2Summary page 1…ctromechanical Ambulatory Infusion Pump Classification Name: Pump, Infusion, PCA Equivalent to: K031249, Stryker PainPumpl; K030661, PainPump2, K040337; I-Flow Elastomeric Pump w/ Bolus Device Description:… | 2003 |
| * | K040337 | I-Flow Elastomeric Pump (on-Q, Painbuster, C-Bloc, Homepump)Summary page 1…nfusion Pump Classification Name: Pump, Infusion, PCA Equivalent to: K031249, Stryker PainPumpl; K030661, PainPump2, K040337; I-Flow Elastomeric Pump w/ Bolus Device Description: PainPump]… | 2004 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 2, 2010 | Not classified | Z-2592-2010 | Nonconforming Material/Component | 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 or external leaks. Some lots have a… |
| Sep 2, 2010 | Not classified | Z-2593-2010 | Nonconforming Material/Component | 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 or external leaks. Some lots have a… |
| Sep 2, 2010 | Not classified | Z-2591-2010 | Nonconforming Material/Component | 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 or external leaks. Some lots have a… |
| Sep 2, 2010 | Not classified | Z-2594-2010 | Nonconforming Material/Component | 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 or external leaks. Some lots have a… |
| Aug 16, 2010 | Not classified | Z-0096-2011 | Other | 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 use the pump around joint spaces. A… |
| Jun 16, 2009 | Not classified | Z-1773-2009 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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. |
The 5 latest of 50 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
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…
Read the full statement (213 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042405: PAINPUMP1; PAINPUMP2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042405
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026