510(k) · Cleared
ClearedZimmer Ambulatory Pump Pain Management Systems with Fenestrated Catheter and Flow Splitter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · FRN Pump, Infusion
Cleared on Jan 31, 2006 as substantially equivalent to K050433 (Zimmer Orthopaedic Surgical Products, 2005) and 3 other predicates after a 75-day review. Its family tree reaches back 9 generations to 1990.
- Decided
- Jan 31, 2006
- Review
- 75 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K896422 (1990). 21 ancestors in all, the oldest K884505 (1989). No later device cites it as a predicate yet.
- Root · 9 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 5 generations between
- 3 generations backK033039 Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsMckinley, Inc. · 2003
- 2 generations backK050433 Zimmer Ambulatory Pump Pain Management SystemZimmer Orthopaedic Surgical Products · 2005
- 1 generation backK052171 Zimmer Ambulatory Pump Pain Management System with Patient Control…Zimmer, Inc. · 2005
- This deviceK053226 Zimmer Ambulatory Pump Pain Management Systems with Fenestrated…Zimmer, Inc. · 2006
Show all 9 generations
- Root · 9 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 8 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
- 7 generations backK982946 Painbuster Infusion KitI-Flow Corp. · 1998
- 6 generations backK984502 Nerve Block Infusion KitI-Flow Corp. · 1999
- 5 generations backK020862 I-Flow Elastomeric PumpI-Flow Corp. · 2002 · Recalled
- 4 generations backK023098 Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser…Mckinley Infuser · 2002
- 3 generations backK033039 Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsMckinley, Inc. · 2003
- 2 generations backK050433 Zimmer Ambulatory Pump Pain Management SystemZimmer Orthopaedic Surgical Products · 2005
- 1 generation backK052171 Zimmer Ambulatory Pump Pain Management System with Patient Control…Zimmer, Inc. · 2005
- This deviceK053226 Zimmer Ambulatory Pump Pain Management Systems with Fenestrated…Zimmer, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| −8 | K980558 | Painbuster Infusion System | I-Flow Corp. | 1998 | — |
| −7 | K982946 | Painbuster Infusion Kit | I-Flow Corp. | 1998 | — |
| −6 | K984502 | Nerve Block Infusion Kit | I-Flow Corp. | 1999 | — |
| −5 | K020862 | I-Flow Elastomeric Pump | I-Flow Corp. | 2002 | 1 |
| −4 | K023098 | Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit | Mckinley Infuser | 2002 | — |
| −3 | K033039 | Modification to: Accufuser, Accufuser Plus, Standard Procedure Kits | Mckinley, Inc. | 2003 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
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? (4)
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 |
|---|---|---|---|
| * | K050433 | Zimmer Ambulatory Pump Pain Management SystemSummary page 3…Predicate Devices: Zimmer Ambulatory Pump Kit Pain Management System manufactured by Zimmer Orthopaedic Surgical Products, K050433, cleared April 13, 2005. Zimmer Ambulatory Pump Kit Pain Management… | 2005 |
| * | K052171 | Zimmer Ambulatory Pump Pain Management System with Patient Control ModuleSummary page 3…Zimmer Ambulatory Pump Kit Pain Management System with PCM, manufactured by Zimmer Orthopaedic Surgical Products, K052171, cleared September 27, 2005. 00… | 2005 |
| * | K033039 | Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsSummary page 4…000034 Accufuser; Accufuser Plus; Standard Procedure Kit, manufactured by McKinley, Inc., K033039, cleared October 7. 2003. Accufuser: Accufuser Plus: Standard Procedure Kit,… | 2003 |
| * | K023098 | Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion KitSummary page 4…October 7. 2003. Accufuser: Accufuser Plus: Standard Procedure Kit, manufactured by McKinley, Inc., K023098. cleared December 9. 2002. Device Description: Accessory kits: The Zimmer Am… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 6 companies; a new generation was cleared every 8 months on median.
- 4 of the 21 ancestors have a recall of any class.
- 1 other device also cites its predicate K050433.
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 Pain Management System and Zimmer Pain Management System with Patient Control Module (PCM) are indicated for the slow, continuous or subcutaneous administration of pain medications. It may also include the slow, continuous infusion of pain medications directly into an intraoperative, or subcutaneous site for postoperative pain management or the continuous infusion of a local anesthetic near a nerve for regional anesthesia. The PCM allows for…
Read the full statement (109 words)
The Zimmer Pain Management System and Zimmer Pain Management System with Patient Control Module (PCM) are indicated for the slow, continuous or subcutaneous administration of pain medications. It may also include the slow, continuous infusion of pain medications directly into an intraoperative, or subcutaneous site for postoperative pain management or the continuous infusion of a local anesthetic near a nerve for regional anesthesia. The PCM allows for intermittent bolus doses of medication on patient demand. The system is convenient for use by ambulatory patients. It is the responsibility of the healthcare provider 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/K053226 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053226: Zimmer Ambulatory Pump Pain Management Systems with Fenestrated Catheter and Flow Splitter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053226
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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