510(k) · Cleared
ClearedDOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemodia Sas · HRX Arthroscope
Cleared on Mar 9, 2023 as substantially equivalent to K203480 (Hemodia Sas, 2021) after a 251-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Mar 9, 2023
- Review
- 251 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954465 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK954465 FMS DuoFuture Medical Systems, Inc. · 1995 · Recalled
- 3 generations backK130169 FMS Vue Fluid Managment System, FMS Connect Interface CableDepuy Mitek, A Johnson & Johnson Company · 2013
- 2 generations backK192921 Zeos Aqua Vision Pump and tubeHemodia Sas · 2020
- 1 generation backK203480 DOUBLEFLO systemHemodia Sas · 2021
- This deviceK221919 DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing setsHemodia Sas · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954465 | FMS Duo | Future Medical Systems, Inc. | 1995 | 2 |
| −3 | 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 | K203480 | DOUBLEFLO system | Hemodia Sas | 2021 | — |
| 0 (this device) | 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 |
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.
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 28 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
- 2 of the 5 ancestors have a recall of any class.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 INFLOW/OUTFLOW PUMP, accessories and tubing sets represents an arthroscopy system using fluid from saline bags (0.9% NaCl). 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 as stated in the FDA summary.
https://510kreport.com/device/K221919 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221919: DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221919
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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