510(k) · Cleared
Recalled · 2009Smith & Nephew 25 Fluid Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HRX Arthroscope
Cleared on Jun 15, 2005 as substantially equivalent to K031605 (Smith & Nephew, Inc., 2003) and 1 other predicate after a 26-day review. Its family tree reaches back 7 generations to 1996. 1 later device descends from it. It has been recalled 6 times.
- Decided
- Jun 15, 2005
- Review
- 26 days
- Class
- Class II
- Product code
- HRX
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 7 generations to K950035 (1996). 18 ancestors in all, the oldest K912453 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK950035 Surgiflator 20W.O.M. GmbH · 1996
- 6 generations backK955791 Surgiflator-20 PimW.O.M. World of Medicine GmbH · 1996
- 5 generations backK981859 Surgiflator-20 EcuW.O.M. World of Medicine GmbH · 1998
- 4 generations backK990443 Arthro-Surgimat-2000 EcuW.O.M. World of Medicine GmbH · 1999
- 3 generations backK030402 Arthroscopy Pump, Model A107W.O.M. World of Medicine AG · 2003
- 2 generations backK033927 Arthoscopy Pump A115W.O.M. World of Medicine AG · 2004
- 1 generation backK050580 Smith & Nephew Intelijet Fluid Management SystemsSmith & Nephew Endoscopy, Inc. · 2005
- This deviceK051326 Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK171794 Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K171794Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K950035 | Surgiflator 20 | W.O.M. GmbH | 1996 | — |
| −6 | K955791 | Surgiflator-20 Pim | W.O.M. World of Medicine GmbH | 1996 | — |
| −5 | K981859 | Surgiflator-20 Ecu | W.O.M. World of Medicine GmbH | 1998 | — |
| −4 | K990443 | Arthro-Surgimat-2000 Ecu | W.O.M. World of Medicine GmbH | 1999 | — |
| −3 | K030402 | Arthroscopy Pump, Model A107 | W.O.M. World of Medicine AG | 2003 | — |
| −2 | K033927 | Arthoscopy Pump A115 | W.O.M. World of Medicine AG | 2004 | — |
| −1 | K050580 | Smith & Nephew Intelijet Fluid Management Systems | Smith & Nephew Endoscopy, Inc. | 2005 | — |
| 0 (this device) | K051326 | Smith & Nephew 25 Fluid Management System | Smith & Nephew, Inc. | 2005 | — |
| +1 | K171794 | Smith & Nephew 25 Fluid Management System | Smith & Nephew, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 HRX? 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 HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 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 |
|---|---|---|---|
| * | K031605 | Intelijet Fluid Management System Hermes-ReadySummary page 1…d Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: The Smith & Nephew InteliJETTM HERMES-Ready (K031605) and Smith & Nephew InteliJETTM Fluid Management Systems (K050580).… | 2003 |
| * | K050580 | Smith & Nephew Intelijet Fluid Management SystemsSummary page 1…marketed device in commercial distribution: The Smith & Nephew InteliJETTM HERMES-Ready (K031605) and Smith & Nephew InteliJETTM Fluid Management Systems (K050580). Smith & Nephew 25… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171794 | Smith & Nephew 25 Fluid Management System | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 27, 2009 | Not classified | Z-2078-2009 | Package design/selection | The sterility of the device cannot be assured |
| May 27, 2009 | Not classified | Z-2077-2009 | Package design/selection | The sterility of the device cannot be assured |
| Aug 7, 2008 | Not classified | Z-2450-2008 | Packaging process control | Integrity of the remote control bag may not be sufficient to prevent tearing or opening of the bag during use. |
| Aug 7, 2008 | Not classified | Z-2451-2008 | Packaging process control | Integrity of the remote control bag may not be sufficient to prevent tearing or opening of the bag during use. |
| Aug 7, 2008 | Not classified | Z-2448-2008 | Packaging process control | Integrity of the remote control bag may not be sufficient to prevent tearing or opening of the bag during use. |
| Aug 7, 2008 | Not classified | Z-2449-2008 | Packaging process control | Integrity of the remote control bag may not be sufficient to prevent tearing or opening of the bag during use. |
The 5 latest of 6 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 9 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 3 of the 18 ancestors have a recall of any class.
- Of its descendants, K171794 (Smith & Nephew, Inc., 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
The Smith & Nephew 25 Fluid Management System is indicated for use during arthroscopic joint surgery to regulate flow of irrigation fluids in the knee, shoulder, hip and small joints to maintain intra-articular pressure for uniform distension and clear visualization of the surgical site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051326 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051326: Smith & Nephew 25 Fluid 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/K051326
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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