510(k) · Cleared
Recalled · 2010Stryker PAINPUMP2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments · MEA Pump, Infusion, Pca
Cleared on May 30, 2003 after an 88-day review. The FDA summary names its predicate without a number. 4 later devices descend from it. It has been recalled 3 times.
- Decided
- May 30, 2003
- Review
- 88 days
- Class
- Class II
- Product code
- MEA
- Recalls
- 3
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK030661 Stryker PAINPUMP2Stryker Instruments · 2003
- Descendant · cites it directly · 3 of its ownK042405 PAINPUMP1; PAINPUMP2Stryker Corp. · 2004 · Recalled
- Descendant · 2 generations on · 1 of its ownK043466 PAINPUMP2Stryker Instruments · 2005 · Recalled
- Descendant · 3 generations on · 0 of its ownK072702 Stryker Antimic CatheterStryker Instruments, Instruments Div. · 2008
- Descendant · 2 generations on · 0 of its ownK052221 Ambit Push & Play Ambulatory Infusion PumpSorenson Medical, Inc. · 2005 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K042405PAINPUMP1; PAINPUMP2Stryker Corp. · 2004 · cites it directly3descendants
- K043466PAINPUMP2Stryker Instruments · 2005 · 2 generations on1descendant
- K072702Stryker Antimic CatheterStryker Instruments, Instruments Div. · 2008 · 3 generations on0descendants
- K052221Ambit Push & Play Ambulatory Infusion PumpSorenson Medical, Inc. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030661 | Stryker PAINPUMP2 | Stryker Instruments | 2003 | — |
| +1 | K042405 | PAINPUMP1; PAINPUMP2 | Stryker Corp. | 2004 | 70 |
| +2 | K043466 | PAINPUMP2 | Stryker Instruments | 2005 | 72 |
| +3 | K072702 | Stryker Antimic Catheter | Stryker Instruments, Instruments Div. | 2008 | — |
| +2 | K052221 | Ambit Push & Play Ambulatory Infusion Pump | Sorenson Medical, Inc. | 2005 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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 MEA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | Existing infusion pump systems marketed by I-Flow Corporation Named without a submission number | |
| * | — | Existing catheters marketed by I-Flow Named without a submission number | |
| * | — | Existing catheters marketed by Sims Portex Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042405 | PAINPUMP1; PAINPUMP2 | 2004 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 1, 2010 | Not classified | Z-2357-2010 | Process control | 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 | Process control | 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 | Process control | Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K042405 (Stryker Corp., 2004) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MEA devicesMEA Pump, Infusion, Pca: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEA
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MEA
Too few MEA 510(k)s in any year since 2007 to give a median.
Recalls per year · MEA
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEA
3,278in 2025
MAUDE reports naming product code MEA, 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 | 0 | — | 0 | 81 |
| 2008 | 1 | — | 1 | 237 |
| 2009 | 1 | — | 0 | 153 |
| 2010 | 0 | — | 4 | 219 |
| 2011 | 0 | — | 2 | 245 |
| 2012 | 0 | — | 0 | 446 |
| 2013 | 1 | — | 0 | 453 |
| 2014 | 0 | — | 1 | 382 |
| 2015 | 0 | — | 0 | 99 |
| 2016 | 1 | — | 0 | 57 |
| 2017 | 2 | — | 2 | 44 |
| 2018 | 0 | — | 0 | 256 |
| 2019 | 0 | — | 0 | 132 |
| 2020 | 0 | — | 0 | 2,331 |
| 2021 | 0 | — | 0 | 3,776 |
| 2022 | 0 | — | 1 | 6,443 |
| 2023 | 0 | — | 0 | 3,984 |
| 2024 | 0 | — | 1 | 4,559 |
| 2025 | 0 | — | 0 | 3,278 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030661 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030661: Stryker PAINPUMP2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030661
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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