510(k) · Cleared
ClearedSmith & 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 27, 2017 as substantially equivalent to K051326 (Smith & Nephew, Inc., 2005) after an 11-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Jun 27, 2017
- Review
- 11 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K950035 (1996). 19 ancestors in all, the oldest K912453 (1991). No later device cites it as a predicate yet.
- Root · 8 generations backK950035 Surgiflator 20W.O.M. GmbH · 1996
- 7 generations backK955791 Surgiflator-20 PimW.O.M. World of Medicine GmbH · 1996
- 6 generations backK981859 Surgiflator-20 EcuW.O.M. World of Medicine GmbH · 1998
- 5 generations backK990443 Arthro-Surgimat-2000 EcuW.O.M. World of Medicine GmbH · 1999
- 4 generations backK030402 Arthroscopy Pump, Model A107W.O.M. World of Medicine AG · 2003
- 3 generations backK033927 Arthoscopy Pump A115W.O.M. World of Medicine AG · 2004
- 2 generations backK050580 Smith & Nephew Intelijet Fluid Management SystemsSmith & Nephew Endoscopy, Inc. · 2005
- 1 generation backK051326 Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc. · 2005 · Recalled
- This deviceK171794 Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K950035 | Surgiflator 20 | W.O.M. GmbH | 1996 | — |
| −7 | K955791 | Surgiflator-20 Pim | W.O.M. World of Medicine GmbH | 1996 | — |
| −6 | K981859 | Surgiflator-20 Ecu | W.O.M. World of Medicine GmbH | 1998 | — |
| −5 | K990443 | Arthro-Surgimat-2000 Ecu | W.O.M. World of Medicine GmbH | 1999 | — |
| −4 | K030402 | Arthroscopy Pump, Model A107 | W.O.M. World of Medicine AG | 2003 | — |
| −3 | K033927 | Arthoscopy Pump A115 | W.O.M. World of Medicine AG | 2004 | — |
| −2 | K050580 | Smith & Nephew Intelijet Fluid Management Systems | Smith & Nephew Endoscopy, Inc. | 2005 | — |
| −1 | K051326 | Smith & Nephew 25 Fluid Management System | Smith & Nephew, Inc. | 2005 | 6 |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K051326 | Smith & Nephew 25 Fluid Management SystemSummary page 4…ntended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Smith & Nephew DYONICS 25 Fluid Management System- K051326. K171794 p 2/3 Description of Device… | 2005 |
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 21 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 19 ancestors have a recall of any class.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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 DYONICS 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171794 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171794: 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/K171794
Report an extraction error
Are you the manufacturer?
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