510(k) · Cleared
ClearedZimmer Ambulatory Pump Pain Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Orthopaedic Surgical Products · FRN Pump, Infusion
Cleared on Apr 13, 2005 as substantially equivalent to K033039 (Mckinley, Inc., 2003) and 1 other predicate after a 50-day review. Its family tree reaches back 7 generations to 1990. 2 later devices descend from it.
- Decided
- Apr 13, 2005
- Review
- 50 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K896422 (1990). 19 ancestors in all, the oldest K884505 (1989). 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 6 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
- 5 generations backK982946 Painbuster Infusion KitI-Flow Corp. · 1998
- 4 generations backK984502 Nerve Block Infusion KitI-Flow Corp. · 1999
- 3 generations backK020862 I-Flow Elastomeric PumpI-Flow Corp. · 2002 · Recalled
- 2 generations backK023098 Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser…Mckinley Infuser · 2002
- 1 generation backK033039 Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsMckinley, Inc. · 2003
- This deviceK050433 Zimmer Ambulatory Pump Pain Management SystemZimmer Orthopaedic Surgical Products · 2005
- Descendant · cites it directly · 1 of its ownK052171 Zimmer Ambulatory Pump Pain Management System with Patient Control…Zimmer, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK053226 Zimmer Ambulatory Pump Pain Management Systems with Fenestrated…Zimmer, Inc. · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| −6 | K980558 | Painbuster Infusion System | I-Flow Corp. | 1998 | — |
| −5 | K982946 | Painbuster Infusion Kit | I-Flow Corp. | 1998 | — |
| −4 | K984502 | Nerve Block Infusion Kit | I-Flow Corp. | 1999 | — |
| −3 | K020862 | I-Flow Elastomeric Pump | I-Flow Corp. | 2002 | 1 |
| −2 | K023098 | Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit | Mckinley Infuser | 2002 | — |
| −1 | K033039 | Modification to: Accufuser, Accufuser Plus, Standard Procedure Kits | Mckinley, Inc. | 2003 | — |
| 0 (this device) | K050433 | Zimmer Ambulatory Pump Pain Management System | Zimmer Orthopaedic Surgical Products | 2005 | — |
| +1 | K052171 | Zimmer Ambulatory Pump Pain Management System with Patient Control Module | Zimmer, Inc. | 2005 | — |
| +1 | K053226 | Zimmer Ambulatory Pump Pain Management Systems with Fenestrated Catheter and… | Zimmer, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033039 | Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsSummary page 1…§ 880.5725 Predicate Devices: Accufuser, Accufluser Plus, & Standard Procedure Kit manufactured by McKinley, Inc., K033039, cleared October 7, 2003. PainPump® Local Anesthesia Kit… | 2003 |
| * | K031249 | Modification to Stryker PainpumpSummary page 1…cleared October 7, 2003. PainPump® Local Anesthesia Kit, manufactured by Stryker Corporation, K03 1249, cleared July 2 1, 2003. Device Description: The Zimmer Ambulatory Pump Pai… | 2003 |
What descends from it? (2)
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?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 4 of the 19 ancestors have a recall of any class.
- Of its descendants, K052171 (Zimmer, Inc., 2005) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K033039.
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 Zimmer Ambulatory Pump Kit, Pain Management System is indicated for patients requiring continuous infusion of medications directly into an intraoperative, subcutaneous or epidural site for postoperative pain management. The system is convenient for use by ambulatory patients. It is the responsibility of the user to assure that the medication is prepared and administered in accordance with the drug manufacturer's package insert.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050433 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050433: Zimmer Ambulatory Pump Pain Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050433
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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