510(k) · Cleared
ClearedModification to Stryker Painpump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments · FRN Pump, Infusion
Cleared on Jul 21, 2003 after a 94-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Jul 21, 2003
- Review
- 94 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK031249 Modification to Stryker PainpumpStryker Instruments · 2003
- Descendant · cites it directly · 3 of its ownK042405 PAINPUMP1; PAINPUMP2Stryker Corp. · 2004 · Recalled
- Descendant · cites it directly · 2 of its ownK050433 Zimmer Ambulatory Pump Pain Management SystemZimmer Orthopaedic Surgical Products · 2005
- Descendant · 2 generations on · 1 of its ownK052171 Zimmer Ambulatory Pump Pain Management System with Patient Control…Zimmer, Inc. · 2005
- 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
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K042405PAINPUMP1; PAINPUMP2Stryker Corp. · 2004 · cites it directly3descendants
- K050433Zimmer Ambulatory Pump Pain Management SystemZimmer Orthopaedic Surgical Products · 2005 · cites it directly2descendants
- K052171Zimmer Ambulatory Pump Pain Management System with Patient Control ModuleZimmer, Inc. · 2005 · 2 generations on1descendant
- K043466PAINPUMP2Stryker Instruments · 2005 · 2 generations on1descendant
- K072702Stryker Antimic CatheterStryker Instruments, Instruments Div. · 2008 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031249 | Modification to Stryker Painpump | Stryker Instruments | 2003 | — |
| +1 | K042405 | PAINPUMP1; PAINPUMP2 | Stryker Corp. | 2004 | 70 |
| +1 | K050433 | Zimmer Ambulatory Pump Pain Management System | Zimmer Orthopaedic Surgical Products | 2005 | — |
| +2 | K052171 | Zimmer Ambulatory Pump Pain Management System with Patient Control Module | Zimmer, Inc. | 2005 | — |
| +2 | K043466 | PAINPUMP2 | Stryker Instruments | 2005 | 72 |
| +3 | K072702 | Stryker Antimic Catheter | Stryker Instruments, Instruments Div. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 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? (6)
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 |
|---|---|---|---|
| * | — | Infusion pump system marketed by Stryker Named without a submission number | |
| * | — | Infusion pump system marketed by I-Flow Corporation Named without a submission number | |
| * | — | Infusion pump system marketed by Sgarlato Named without a submission number | |
| * | — | Catheter marketed by Stryker Named without a submission number | |
| * | — | Catheter marketed by I-Flow Named without a submission number | |
| * | — | Catheter marketed by Sims Porter Named without a submission number |
What descends from it? (7)
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)
No FDA recall names this device.
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 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?
The Stryker PainPump 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 through intramuscular or subcutaneous routes,
The Stryker PainPurnp 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/K031249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031249: Modification to Stryker Painpump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031249
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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