510(k) · Cleared
Recalled · Class II · 2013FMS Solo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Future Medical Systems, Inc. · HRX Arthroscope
Cleared on Sep 11, 2000 after a 68-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 10 later devices descend from it. It has been recalled once.
- Decided
- Sep 11, 2000
- Review
- 68 days
- Class
- Class II
- Product code
- HRX
- Recalls
- 1
- Predicates
- 0
10 later devices descend from it, 3 citing it directly.
- This deviceK002040 FMS SoloFuture Medical Systems, Inc. · 2000
- Descendant · cites it directly · 5 of its ownK130169 FMS Vue Fluid Managment System, FMS Connect Interface CableDepuy Mitek, A Johnson & Johnson Company · 2013
- Descendant · 2 generations on · 2 of its ownK192921 Zeos Aqua Vision Pump and tubeHemodia Sas · 2020
- Descendant · cites it directly · 2 of its ownK050580 Smith & Nephew Intelijet Fluid Management SystemsSmith & Nephew Endoscopy, Inc. · 2005
- Descendant · 3 generations on · 1 of its ownK203480 DOUBLEFLO systemHemodia Sas · 2021
- Descendant · 2 generations on · 1 of its ownK051326 Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc. · 2005 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K130169FMS Vue Fluid Managment System, FMS Connect Interface CableDepuy Mitek, A Johnson & Johnson Company · 2013 · cites it directly5descendants
- K192921Zeos Aqua Vision Pump and tubeHemodia Sas · 2020 · 2 generations on2descendants
- K050580Smith & Nephew Intelijet Fluid Management SystemsSmith & Nephew Endoscopy, Inc. · 2005 · cites it directly2descendants
- K203480DOUBLEFLO systemHemodia Sas · 2021 · 3 generations on1descendant
- K051326Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc. · 2005 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002040 | FMS Solo | Future Medical Systems, Inc. | 2000 | — |
| +1 | K130169 | FMS Vue Fluid Managment System, FMS Connect Interface Cable | Depuy Mitek, A Johnson & Johnson Company | 2013 | — |
| +2 | K192921 | Zeos Aqua Vision Pump and tube | Hemodia Sas | 2020 | — |
| +1 | K050580 | Smith & Nephew Intelijet Fluid Management Systems | Smith & Nephew Endoscopy, Inc. | 2005 | — |
| +3 | K203480 | DOUBLEFLO system | Hemodia Sas | 2021 | — |
| +2 | K051326 | Smith & Nephew 25 Fluid Management System | Smith & Nephew, Inc. | 2005 | 6 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2013 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (10)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 29, 2013 | Class II | Z-0192-2014 | Component change control | Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K130169 (Depuy Mitek, A Johnson & Johnson Company, 2013) has gone furthest, with 5 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 | — |
https://510kreport.com/device/K002040 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002040: FMS Solo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002040
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026