510(k) · Cleared
ClearedPurevue™ FMS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W.O.M. World of Medicine GmbH · HRX Arthroscope
Cleared on Dec 5, 2025 as substantially equivalent to K123441 (Stryker Endoscopy, 2013) after a 266-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Dec 5, 2025
- Review
- 266 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K950035 (1996). 11 ancestors in all, the oldest K912453 (1991). No later device cites it as a predicate yet.
- Root · 6 generations backK950035 Surgiflator 20W.O.M. GmbH · 1996
- 5 generations backK955791 Surgiflator-20 PimW.O.M. World of Medicine GmbH · 1996
- 4 generations backK981859 Surgiflator-20 EcuW.O.M. World of Medicine GmbH · 1998
- 3 generations backK990443 Arthro-Surgimat-2000 EcuW.O.M. World of Medicine GmbH · 1999
- 2 generations backK030402 Arthroscopy Pump, Model A107W.O.M. World of Medicine AG · 2003
- 1 generation backK123441 Stryker Crossflow Arthroscopy PumpStryker Endoscopy · 2013
- This deviceK250795 Purevue™ FMSW.O.M. World of Medicine GmbH · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K950035 | Surgiflator 20 | W.O.M. GmbH | 1996 | — |
| −5 | K955791 | Surgiflator-20 Pim | W.O.M. World of Medicine GmbH | 1996 | — |
| −4 | K981859 | Surgiflator-20 Ecu | W.O.M. World of Medicine GmbH | 1998 | — |
| −3 | K990443 | Arthro-Surgimat-2000 Ecu | W.O.M. World of Medicine GmbH | 1999 | — |
| −2 | K030402 | Arthroscopy Pump, Model A107 | W.O.M. World of Medicine AG | 2003 | — |
| −1 | K123441 | Stryker Crossflow Arthroscopy Pump | Stryker Endoscopy | 2013 | — |
| 0 (this device) | K250795 | Purevue™ FMS | W.O.M. World of Medicine GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 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 |
|---|---|---|---|
| * | K123441 | Stryker Crossflow Arthroscopy PumpSummary page 5…HRX Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # K123441 Predicate Trade Name Stryker CrossFlow Integrated Arthroscopy… | 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 4 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 11 ancestors has a recall of any class.
- 2 other devices also cite its predicate K123441.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 PUREVUE™ FMS is a dual arthroscopic pump system intended to provide fluid distension and irrigation of knee,
shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during diagnostic and operative arthroscopic
procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250795 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250795: Purevue™ FMS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250795
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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