510(k) · Cleared
ClearedDOUBLEFLO system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemodia Sas · HRX Arthroscope
Cleared on Apr 5, 2021 as substantially equivalent to K192921 (Hemodia Sas, 2020) after a 129-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- Apr 5, 2021
- Review
- 129 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K954465 (1995). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK954465 FMS DuoFuture Medical Systems, Inc. · 1995 · Recalled
- 2 generations backK130169 FMS Vue Fluid Managment System, FMS Connect Interface CableDepuy Mitek, A Johnson & Johnson Company · 2013
- 1 generation backK192921 Zeos Aqua Vision Pump and tubeHemodia Sas · 2020
- This deviceK203480 DOUBLEFLO systemHemodia Sas · 2021
- Descendant · cites it directly · 0 of its ownK221919 DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing setsHemodia Sas · 2023
Most influential descendants
Showing 1 of 1 · See all- K221919DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing setsHemodia Sas · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954465 | FMS Duo | Future Medical Systems, Inc. | 1995 | 2 |
| −2 | 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 | — |
| 0 (this device) | K203480 | DOUBLEFLO system | Hemodia Sas | 2021 | — |
| +1 | K221919 | DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets | Hemodia Sas | 2023 | — |
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 |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K192921 | Zeos Aqua Vision Pump and tubeSummary page 5…Panel: Orthopedic Regulatory Class: II Product Code: HRX 51Ok # K203480 IV PREDICATE DEVICE K192921 - ZEOS Aqua Vision Pump and tubing sets Page 2 of 14 ===… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221919 | DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets | 2023 | 0 |
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 26 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K221919 (Hemodia Sas, 2023) has gone furthest, with 0 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. 2021, 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 DOUBLEFLO system represents an arthroscopy system using fluid from saline bags (0.9% NaCI). This arthroscopy system is intended to provide fluid distension and irrigation of the knee, shoulder, hip. elbow, ankle and wrist joint cavities, and fluid suction during arthroscopy procedures.
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/K203480 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203480: DOUBLEFLO system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203480
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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