510(k) · Cleared
ClearedFMS VUE™ Fluid Management and Tissue Debridement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Mitek, Inc. · HRX Arthroscope
Cleared on Feb 26, 2024 as substantially equivalent to K130169 (Depuy Mitek, A Johnson & Johnson Company, 2013) after a 102-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Feb 26, 2024
- Review
- 102 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954465 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK954465 FMS DuoFuture Medical Systems, Inc. · 1995 · Recalled
- 1 generation backK130169 FMS Vue Fluid Managment System, FMS Connect Interface CableDepuy Mitek, A Johnson & Johnson Company · 2013
- This deviceK233675 FMS VUE™ Fluid Management and Tissue Debridement SystemDePuy Mitek, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954465 | FMS Duo | Future Medical Systems, Inc. | 1995 | 2 |
| −1 | K130169 | FMS Vue Fluid Managment System, FMS Connect Interface Cable | Depuy Mitek, A Johnson & Johnson Company | 2013 | — |
| 0 (this device) | K233675 | FMS VUE™ Fluid Management and Tissue Debridement System | DePuy Mitek, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 |
|---|---|---|---|
| * | K130169 | FMS Vue Fluid Managment System, FMS Connect Interface CableSummary page 5…Regulatory Class Class II Product Code HRX The FMS VUE Fluid Management and Tissue Debridement System Predicate Device (K130169) No reference devices were used in this submission. The FMS VUE Fluid Management an… | 2013 |
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 29 years and passes through 3 companies; a new generation was cleared every 17.5 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 2 other devices also cite its predicate K130169.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 FMS VUETM 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233675 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233675: FMS VUE™ Fluid Management and Tissue Debridement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233675
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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