510(k) · Cleared
ClearedIRRAflow Active Fluid Exchange System (AFES)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Irras USA · JXG Shunt, Central Nervous System And Components
Cleared on Dec 8, 2022 as substantially equivalent to K200807 (Irras USA, Inc., 2020) and 1 other predicate after a 114-day review. Its family tree reaches back 6 generations to 2001. 1 of the 11 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Dec 8, 2022
- Review
- 114 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K011812 (2001). 9 ancestors in all, the oldest K902257 (1990). 1 later device descends from it, 1 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK011812 Spectrum Ventricular CatheterCook, Inc. · 2001 · Recalled
- 5 generations backK071640 Ventriclear II, Spectrum Ventricular Drainage Catheter, Model…Cook, Inc. · 2007 · Recalled
- 4 generations backK160223 VentriClear Ventricular Drainage Catheter Set with Cook Spectrum…Cook Incorporated · 2016
- 3 generations backK171880 IRRAflow CNS SystemIrras, Inc. · 2018
- 2 generations backK192289 IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitIrras USA, Ltd. · 2019
- 1 generation backK200807 IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitIrras USA, Inc. · 2020
- This deviceK222471 IRRAflow Active Fluid Exchange System (AFES)Irras USA · 2022
- Descendant · cites it directly · 0 of its ownK231664 IRRAflow Active Fluid Exchange System (AFES)Irras USA, Inc. · 2023
Class I recalls in this family
- K984053 Becker External Drainage and Monitoring System3 generations back · 1999
Most influential descendants
Showing 1 of 1 · See all- K231664IRRAflow Active Fluid Exchange System (AFES)Irras USA, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K011812 | Spectrum Ventricular Catheter | Cook, Inc. | 2001 | 1 |
| −5 | K071640 | Ventriclear II, Spectrum Ventricular Drainage Catheter, Model N-VVDC-02-Abrm | Cook, Inc. | 2007 | 1 |
| −4 | K160223 | VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic… | Cook Incorporated | 2016 | — |
| −3 | K171880 | IRRAflow CNS System | Irras, Inc. | 2018 | — |
| −2 | K192289 | IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit | Irras USA, Ltd. | 2019 | — |
| −1 | K200807 | IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit | Irras USA, Inc. | 2020 | — |
| 0 (this device) | K222471 | IRRAflow Active Fluid Exchange System (AFES) | Irras USA | 2022 | — |
| +1 | K231664 | IRRAflow Active Fluid Exchange System (AFES) | Irras USA, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1999 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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 JXG device
- #1 K243531 Codman Libertís Shunt Catheter with Bactiseal…score 11.9 · 8 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 |
|---|---|---|---|
| * | K200807 | IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitSummary page 5…Intracranial Pressure Monitoring Device Product Code: GWM Regulation: 21 CFR 882.1620 Primary Predicate Device: IRRAflow® CNS System, K200807 Additional Predicate Device: IRRAflow® CNS System, Kl92289 1.0 DEVICE DESCRIPTION - IRRAflow® Active Fluid Exchange Syst… | 2020 |
| * | K192289 | IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitSummary page 6…to affect the technological characteristics or principles of operation of the IRRAflow® System were evaluated by design controls. Earlier predicate devices described in K192289 and K200807 are shown for comparison in Table 2 below. Comparison of these Monitoring Systems will show that the only difference… | 2019 |
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 |
|---|---|---|---|
| K231664 | IRRAflow Active Fluid Exchange System (AFES) | 2023 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K984053Becker External Drainage and Monitoring SystemMedtronic PS Medical · 1999 · 3 generations back · ◆ in the 1999 ancestors bar of FIG. 15 Class I recalls
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 3 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K231664 (Irras USA, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JXG devicesJXG Shunt, Central Nervous System And Components: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · JXG
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JXG
255in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JXG
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JXG
1,198in 2025
MAUDE reports naming product code JXG, 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 | 3 | 184 | 0 | 649 |
| 2008 | 6 | 60 | 1 | 630 |
| 2009 | 5 | 106 | 30 | 629 |
| 2010 | 3 | 30 | 0 | 812 |
| 2011 | 7 | 136 | 5 | 787 |
| 2012 | 3 | 78 | 1 | 977 |
| 2013 | 3 | 108 | 14 | 1,004 |
| 2014 | 0 | — | 6 | 1,251 |
| 2015 | 6 | 276 | 0 | 984 |
| 2016 | 6 | 143 | 0 | 1,091 |
| 2017 | 7 | 90 | 1 | 1,335 |
| 2018 | 6 | 102 | 0 | 1,484 |
| 2019 | 4 | 101 | 0 | 1,295 |
| 2020 | 2 | — | 8 | 1,206 |
| 2021 | 1 | — | 0 | 1,467 |
| 2022 | 4 | 101 | 0 | 1,329 |
| 2023 | 5 | 134 | 2 | 1,221 |
| 2024 | 3 | 90 | 3 | 1,214 |
| 2025 | 8 | 255 | 0 | 1,198 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The use of IRRAflow Active Fluid Exchange System is indicated when intracranial pressure monitoring is required
and for externally draining intracranial fluid as a means of reducing intracranial pressure in patients where an external
drainage and monitoring system is needed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222471 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222471: IRRAflow Active Fluid Exchange System (AFES).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222471
Report an extraction error
Are you the manufacturer?
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