510(k) · Cleared
Recalled · Class I · 2023Becker External Drainage and Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic PS Medical · JXG Shunt, Central Nervous System And Components
Cleared on Feb 4, 1999 as substantially equivalent to K902257 (Codman & Shurtleff, Inc., 1990) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1990. 2 of the 16 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it. It has been recalled 6 times, including 5 Class I recalls.
- Decided
- Feb 4, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- JXG
- Recalls
- 6 (5 Class I)
- Predicates
- 2
Its longest line of descent runs back 1 generation to K902257 (1990). 2 ancestors in all. 13 later devices descend from it, 5 citing it directly. 2 of the 16 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK902257 Codman* External Drainage System II (Eds-II)Codman & Shurtleff, Inc. · 1990
- This deviceK984053 Becker External Drainage and Monitoring SystemMedtronic PS Medical · 1999
- Descendant · cites it directly · 4 of its ownK171880 IRRAflow CNS SystemIrras, Inc. · 2018
- Descendant · cites it directly · 4 of its ownK161605 Smart External Drain (SED) SystemAqueduct Critical Care, Inc. · 2016
- Descendant · 2 generations on · 3 of its ownK192289 IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitIrras USA, Ltd. · 2019
- Descendant · 2 generations on · 3 of its ownK171586 Smart External Drain (SED) SystemAqueduct Critical Care, Inc. · 2017
- Descendant · 2 generations on · 2 of its ownK200807 IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitIrras USA, Inc. · 2020
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K200456 Becker External Drainage and Monitoring Systemcites it directly · 2020
Most influential descendants
Showing 5 of 13 · See all- K171880IRRAflow CNS SystemIrras, Inc. · 2018 · cites it directly4descendants
- K161605Smart External Drain (SED) SystemAqueduct Critical Care, Inc. · 2016 · cites it directly4descendants
- K192289IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitIrras USA, Ltd. · 2019 · 2 generations on3descendants
- K171586Smart External Drain (SED) SystemAqueduct Critical Care, Inc. · 2017 · 2 generations on3descendants
- K200807IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitIrras USA, Inc. · 2020 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902257 | Codman* External Drainage System II (Eds-II) | Codman & Shurtleff, Inc. | 1990 | — |
| 0 (this device) | K984053 | Becker External Drainage and Monitoring System | Medtronic PS Medical | 1999 | — |
| +1 | K171880 | IRRAflow CNS System | Irras, Inc. | 2018 | — |
| +1 | K161605 | Smart External Drain (SED) System | Aqueduct Critical Care, Inc. | 2016 | — |
| +2 | K192289 | IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit | Irras USA, Ltd. | 2019 | — |
| +2 | K171586 | Smart External Drain (SED) System | Aqueduct Critical Care, Inc. | 2017 | — |
| +2 | K200807 | IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit | Irras USA, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 1 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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.
2 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? (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 |
|---|---|---|---|
| * | K902257 | Codman* External Drainage System II (Eds-II)Summary page 1…ronic PS Medical has, with input from neurosurgeons, developed a device design, which is considered to be equivalent to the predicate Codman External Drainage System [l (K902257, The Medtronic PS Medical Becker EDMS is a complete closed system irfdicated for the draining and monitoring of CSF flow from the… | 1990 |
| * | K910938 | Codman External Drainage System II (Eds II) Our OCR of the scanned summary read K920938, FDA’s number for VJW2919 Pneumatic Compression Upgrade (Varian Canada, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Codman External Drainage System II”. | 1991 |
What descends from it? (13)
See all 135 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 28, 2023 | Class II | Z-2412-2023 | Labeling Change Control | Product labeling contains incorrect expiration date |
| Jun 9, 2014 | Class I | Z-1920-2014 | Device Design | Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock. |
| Jun 9, 2014 | Class I | Z-1923-2014 | Device Design | Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock. |
| Jun 9, 2014 | Class I | Z-1921-2014 | Device Design | Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock. |
| Jun 9, 2014 | Class I | Z-1922-2014 | Device Design | Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock. |
| Jun 9, 2014 | Class I | Z-1924-2014 | Device Design | Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock. |
The 5 latest of 6 recalls; the web page lists all.
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.
- K200456Becker External Drainage and Monitoring SystemMedtronic, Inc. · 2020 · Cites it directly · ◆ in the 2020 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
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.
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?
Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to reduce intracranial pressure (ICP), e.g. pre-intra- or postoperative; monitor CSF chemistry, cytology and physiology; provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts. The monitoring of the intracranial pressure (ICP) is indicated in selected patients with severe head injury; subarachnoid…
Read the full statement (105 words)
Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to reduce intracranial pressure (ICP), e.g. pre-intra- or postoperative; monitor CSF chemistry, cytology and physiology; provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts. The monitoring of the intracranial pressure (ICP) is indicated in selected patients with severe head injury; subarachnoid hemorrhage graded lii, IV or V preoperatively; Reyes syndrome or similar encephalopathies; hydrocephalus; intracranial hemorrhage or miscellaneous problems when drainage is to be used as a therapeutic maneuver. Monitoring can also be used to evaluate the status pre-and postoperatively for space occupying lesions.
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/K984053 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984053: Becker External Drainage and Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984053
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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