510(k) Report

510(k) · Cleared

Recalled · 2010

PAINPUMP2

K043466510(k) TraditionalCleared May 10, 2005146-day reviewClass II21 CFR 880.5725Recalls 72

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stryker Instruments · FRN Pump, Infusion

Cleared on May 10, 2005 as substantially equivalent to K042405 (Stryker Corp., 2004) and 1 other predicate after a 146-day review. Its family tree reaches back 2 generations to 2003. 1 later device descends from it. It has been recalled 72 times.

Decided
May 10, 2005
Review
146 days
Class
Class II
Product code
FRN
Recalls
72
Predicates
2

Its longest line of descent runs back 2 generations to K030661 (2003). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2003: 1 other ancestor2008: 1 descendant clearedK030661 · Stryker PAINPUMP2 · Stryker Instruments · 2003 · recalledK042405 · PAINPUMP1; PAINPUMP2 · Stryker Corp. · 2004 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor 1 generation forward: 1 descendant K042405 · PAINPUMP1; PAINPUMP2 · Stryker Corp. · 2004 · recalledK030661 · Stryker PAINPUMP2 · Stryker Instruments · 2003 · recalled0
  1. Root · 2 generations backK030661 Stryker PAINPUMP2Stryker Instruments · 2003 · Recalled
  2. 1 generation backK042405 PAINPUMP1; PAINPUMP2Stryker Corp. · 2004 · Recalled
  3. This deviceK043466 PAINPUMP2Stryker Instruments · 2005
  4. Descendant · cites it directly · 0 of its ownK072702 Stryker Antimic CatheterStryker Instruments, Instruments Div. · 2008

Most influential descendants

Showing 1 of 1 · See all
  • K072702Stryker Antimic CatheterStryker Instruments, Instruments Div. · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K030661Stryker PAINPUMP2Stryker Instruments20033
−1K042405PAINPUMP1; PAINPUMP2Stryker Corp.200470
0 (this device)K043466PAINPUMP2Stryker Instruments2005—
+1K072702Stryker Antimic CatheterStryker Instruments, Instruments Div.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
FIG. 1 — Lineage of K043466, 2003–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K042405PAINPUMP1; PAINPUMP2
Summary page 1
…In fusion Pump; Flectromrechanrical Ambulatory Infusion Ptimp Classification Name: Pump, Infusion, I'CA Equivalent to: K042405, Stryker PainflumplI and Stryker PainPump2; K040337, (-how Flastomneric Pump w/ Bolus Device Description: PainPu…
Stryker Corp.200470
*K040337I-Flow Elastomeric Pump (on-Q, Painbuster, C-Bloc, Homepump)
Summary page 1
…bulatory Infusion Ptimp Classification Name: Pump, Infusion, I'CA Equivalent to: K042405, Stryker PainflumplI and Stryker PainPump2; K040337, (-how Flastomneric Pump w/ Bolus Device Description: PainPump2 PaintPump2 is…
I-Flow Corp.2004—

Also cleared against K042405: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K072702Stryker Antimic CatheterStryker Instruments, Instruments Div.20080

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Sep 2, 2010Not classifiedZ-2593-2010Nonconforming Material/ComponentAll 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, 2010Not classifiedZ-2592-2010Nonconforming Material/ComponentAll 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, 2010Not classifiedZ-2594-2010Nonconforming Material/ComponentAll 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, 2010Not classifiedZ-2591-2010Nonconforming Material/ComponentAll 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, 2010Not classifiedZ-0096-2011OtherThe 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, 2009Not classifiedZ-1757-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1769-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1740-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1770-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1746-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1778-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1758-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1784-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1766-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1749-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1781-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1763-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1786-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1756-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1775-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1744-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1736-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1774-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1779-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1764-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1776-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1773-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1771-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1752-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1772-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1760-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1755-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1742-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1788-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1745-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1785-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1762-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1765-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1777-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1780-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1750-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1737-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1761-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1747-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1738-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1787-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1741-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1759-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1739-2009Nonconforming Material/ComponentThe 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, 2009Not classifiedZ-1743-2009Nonconforming Material/ComponentThe 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?

  • The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
  • 2 of the 4 ancestors have a recall of any class.
  • Of its descendants, K072702 (Stryker Instruments, Instruments Div., 2008) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K042405.

How does its category compare?

All FRN devices

FRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRN

8in 2025

2007: 122008: 82009: 92010: 32011: 32012: 42013: 62014: 62015: 32016: 32017: 32018: 32019: 22020: 12021: 22022: 62023: 72024: 52025: 82026 (partial year): 2
2007high 12 (2007) · low 1 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRN

172in 2025

2007: 102 days median2008: 89 days median2009: 66 days median2010: 93 days median2011: 103 days median2012: 217 days median2013: 312 days median2014: 172 days median2015: 232 days median2016: 301 days median2017: 305 days median2018: 267 days median2022: 268 days median2023: 265 days median2024: 103 days median2025: 172 days median
2007high 312 (2013) · low 66 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRN

7in 2025

2007: 152008: 242009: 1022010: 372011: 692012: 42, 2 Class I2013: 22, 3 Class I2014: 4, 3 Class I2015: 52016: 7, 1 Class I2017: 132018: 12019: 18, 1 Class I2020: 16, 5 Class I2021: 3, 2 Class I2022: 22023: 16, 10 Class I2024: 9, 4 Class I2025: 7, 4 Class I2026 (partial year): 11, 2 Class I
2007high 102 (2009) · low 1 (2018)2026

Class I (37 since 2007) Class II/III not classified

Adverse event reports per year · FRN

52,792in 2025

2007: 1,0862008: 8,2612009: 1,9522010: 6,1332011: 41,3672012: 15,4822013: 40,0822014: 94,1802015: 26,7422016: 16,5602017: 12,0602018: 16,5912019: 15,8502020: 94,1862021: 199,3422022: 888,0202023: 165,8382024: 57,7302025: 52,792
2007high 888,020 (2022) · low 1,086 (2007)2025

MAUDE reports naming product code FRN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200712102151,086
2008889248,261
20099661021,952
2010393376,133
201131036941,367
2012421742 (2)15,482
2013631222 (3)40,082
201461724 (3)94,180
20153232526,742
201633017 (1)16,560
201733051312,060
20183267116,591
20192—18 (1)15,850
20201—16 (5)94,186
20212—3 (2)199,342
202262682888,020
2023726516 (10)165,838
202451039 (4)57,730
202581727 (4)52,792
20262—11 (2)—

What is it indicated for?

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…

Read the full statement (163 words)

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.

Indications for use as stated in the FDA summary.

Also cleared against K042405

1 other device cites the same predicate.

  • K052221Ambit Push & Play Ambulatory Infusion PumpSorenson Medical, Inc. · 20054 recalls

More from Stryker Instruments

77 FDA decisions under this applicant name. See the company

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  • K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch…Stryker Instruments · 2026
  • K261544Hydro Irrigation SystemStryker Instruments · 2026
  • K253679Hydro Irrigation SystemStryker Instruments · 2026

Recent decisions in FRN

The FRN category page

  • K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D Corp · 2026
  • K252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc. · 2026
  • K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare Corporation · 20251 recall
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  • K242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation · 2025

https://510kreport.com/device/K043466 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043466: PAINPUMP2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043466

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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