510(k) · Cleared
ClearedFMS Vue Fluid Managment System, FMS Connect Interface Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Mitek, A Johnson & Johnson Company · HRX Arthroscope
Cleared on May 1, 2013 as substantially equivalent to K954465 (Future Medical Systems, Inc., 1995) and 1 other predicate after a 97-day review. Its family tree reaches back 1 generation to 1995. 5 later devices descend from it.
- Decided
- May 1, 2013
- Review
- 97 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K954465 (1995). 2 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK954465 FMS DuoFuture Medical Systems, Inc. · 1995 · Recalled
- This deviceK130169 FMS Vue Fluid Managment System, FMS Connect Interface CableDepuy Mitek, A Johnson & Johnson Company · 2013
- Descendant · cites it directly · 2 of its ownK192921 Zeos Aqua Vision Pump and tubeHemodia Sas · 2020
- Descendant · 2 generations on · 1 of its ownK203480 DOUBLEFLO systemHemodia Sas · 2021
- Descendant · cites it directly · 0 of its ownK233675 FMS VUE™ Fluid Management and Tissue Debridement SystemDePuy Mitek, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK221919 DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing setsHemodia Sas · 2023
- Descendant · cites it directly · 0 of its ownK171237 FMS VUE II Fluid Management and Tissue Debridement SystemMedos International SARL · 2018
Most influential descendants
Showing 5 of 5 · See all- K192921Zeos Aqua Vision Pump and tubeHemodia Sas · 2020 · cites it directly2descendants
- K203480DOUBLEFLO systemHemodia Sas · 2021 · 2 generations on1descendant
- K233675FMS VUE™ Fluid Management and Tissue Debridement SystemDePuy Mitek, Inc. · 2024 · cites it directly0descendants
- K221919DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing setsHemodia Sas · 2023 · 3 generations on0descendants
- K171237FMS VUE II Fluid Management and Tissue Debridement SystemMedos International SARL · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954465 | FMS Duo | Future Medical Systems, Inc. | 1995 | 2 |
| 0 (this device) | K130169 | FMS Vue Fluid Managment System, FMS Connect Interface Cable | Depuy Mitek, A Johnson & Johnson Company | 2013 | — |
| +1 | K192921 | Zeos Aqua Vision Pump and tube | Hemodia Sas | 2020 | — |
| +2 | K203480 | DOUBLEFLO system | Hemodia Sas | 2021 | — |
| +1 | K233675 | FMS VUE™ Fluid Management and Tissue Debridement System | DePuy Mitek, Inc. | 2024 | — |
| +3 | K221919 | DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets | Hemodia Sas | 2023 | — |
| +1 | K171237 | FMS VUE II Fluid Management and Tissue Debridement System | Medos International SARL | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K954465 | FMS DuoSummary page 1…ement & Tissue Device(s) Debridemnent System, and FMS Connedt Interface Cable are substantially equivalent to: *K954465 FMS DUO (November 9, 1995) *K002040 EMS SOLO (September 11, 2000) Device The EMS VUE is… | 1995 |
| * | K002040 | FMS SoloSummary page 1…MS Connedt Interface Cable are substantially equivalent to: *K954465 FMS DUO (November 9, 1995) *K002040 EMS SOLO (September 11, 2000) Device The EMS VUE is DePuy Mitek's next generation of Fluid Management Desdflption… | 2000 |
What descends from it? (5)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
DePuy Mitek FMS VUE Fluid Management and Tissue Debridement System is intended to provide controlled fluid distention and suction, controlled cutting, burring, shaving and abrading of bone and tissue for use in arthroscopic surgery of the shoulder, knee, ankle, elbow, wrist and hip joints.
The FMS CONNECT Interface Cables are accessories to the DePuy Mitek FMS Fluid Management and Tissue Debridement Systems; they connect competitive shavers to FMS arthroscopy pumps.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130169 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130169: FMS Vue Fluid Managment System, FMS Connect Interface Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130169
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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