510(k) · Cleared
ClearedExternal Drainage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jmed (Shenzhen) Technology Limited · JXG Shunt, Central Nervous System And Components
Cleared on Feb 9, 2023 as substantially equivalent to K191684 (Integra LifeSciences Corporation, 2019) after a 244-day review. Its family tree reaches back 4 generations to 1992. 3 of the 5 devices in its family, counting itself, have a Class I recall.
- Decided
- Feb 9, 2023
- Review
- 244 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K920156 (1992). No later device cites it as a predicate yet. 3 of the 5 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK920156 Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SYClinical Neuro Systems, LLC · 1992 · Recalled (Class I)
- 3 generations backK022554 Monitorr Icp External CSF Drainage and Monitoring SystemIntegra Neurosciences · 2002 · Recalled (Class I)
- 2 generations backK072929 Limitorr Volume Limiting External CSF Drainage and Monitoring…Integra LifeSciences Corporation · 2007 · Recalled (Class I)
- 1 generation backK191684 MoniTorr ICP External Drainage and Monitoring System, LimiTorr…Integra LifeSciences Corporation · 2019
- This deviceK221694 External Drainage SystemJmed (Shenzhen) Technology Limited · 2023
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K920156 | Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SY | Clinical Neuro Systems, LLC | 1992 | Class I |
| −3 | K022554 | Monitorr Icp External CSF Drainage and Monitoring System | Integra Neurosciences | 2002 | Class I |
| −2 | K072929 | Limitorr Volume Limiting External CSF Drainage and Monitoring System, Models… | Integra LifeSciences Corporation | 2007 | Class I |
| −1 | K191684 | MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting… | Integra LifeSciences Corporation | 2019 | — |
| 0 (this device) | K221694 | External Drainage System | Jmed (Shenzhen) Technology Limited | 2023 | — |
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.
3 devices in this family have 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? (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 |
|---|---|---|---|
| * | K191684 | MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External…Summary page 4…Central Nervous System Fluid Shunt and Components Device Regulation: 21 CFR 882.5550 Device Classification: Class II Product Code: JXG 5 Predicate Device 510(k) Number: K191684 Trade Name: MoniTorr ICP™ External CSF Drainage and Monitoring System; LimiTorr™ Volume Limiting External CSF Drainage and Monito… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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.
- K072929Limitorr Volume Limiting External CSF Drainage and Monitoring System, Models INS9020, INS9030Integra LifeSciences Corporation · 2007 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K022554Monitorr Icp External CSF Drainage and Monitoring SystemIntegra Neurosciences · 2002 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K920156Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SYClinical Neuro Systems, LLC · 1992 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 31 years and passes through 4 companies; a new generation was cleared every 10.4 years on median.
- 3 of the 4 ancestors have a recall of any class; 3 have a Class I recall.
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. 2023, 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?
External Drainage System allows for drainage of cerebrospinal fluid (CSF) from the lateral ventricles of the brain and the
lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221694 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221694: External Drainage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221694
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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