510(k) · Cleared
Recalled · Class II · 2023Codman EDS3 CSF External Drainage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codman & Shurtleff, Inc. · JXG Shunt, Central Nervous System And Components
Cleared on Oct 28, 2016 as substantially equivalent to K061568 (Codman & Shurtleff, Inc., 2006) after a 58-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Oct 28, 2016
- Review
- 58 days
- Class
- Class II
- Product code
- JXG
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K902257 (1990). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK902257 Codman* External Drainage System II (Eds-II)Codman & Shurtleff, Inc. · 1990
- 1 generation backK061568 Codman Eds 3 CSF External Drainage System, Models 82-1730, 82-1731…Codman & Shurtleff, Inc. · 2006 · Recalled
- This deviceK162437 Codman EDS3 CSF External Drainage SystemCodman & Shurtleff, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK172537 Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External…Codman & Shurtleff, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K172537Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System…Codman & Shurtleff, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902257 | Codman* External Drainage System II (Eds-II) | Codman & Shurtleff, Inc. | 1990 | — |
| −1 | K061568 | Codman Eds 3 CSF External Drainage System, Models 82-1730, 82-1731, 82-1732… | Codman & Shurtleff, Inc. | 2006 | 3 |
| 0 (this device) | K162437 | Codman EDS3 CSF External Drainage System | Codman & Shurtleff, Inc. | 2016 | — |
| +1 | K172537 | Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage… | Codman & Shurtleff, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 JXG? 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 |
|---|---|---|---|
| * | K061568 | Codman Eds 3 CSF External Drainage System, Models 82-1730, 82-1731, 82-1732, 82-1733…Summary page 4…Product Code JXG III. Predicate The predicate device for this submission is the Codman EDS3 CSF Device External Drainage System (K061568), which was cleared on September 29, 2006. IV. Device The Codman EDS3 CSF External Drainage System (Codm… | 2006 |
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 |
|---|---|---|---|
| K172537 | Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System… | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 28, 2023 | Class II | Z-0634-2024 | Process change control | Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing. |
| Nov 28, 2023 | Class II | Z-0635-2024 | Process change control | Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing. |
| Jan 12, 2021 | Class II | Z-1143-2021 | Release of Material/Component prior to receiving test results | The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 1 company; a new generation was cleared every 16.2 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K172537 (Codman & Shurtleff, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K061568.
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. 2016, 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?
Use of the Codman EDS3 CSF External Drainage System is indicated for draining cerebrospinal fluid (CSF) from the cerebral ventricles or the lumbar subarachnoid space as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162437: Codman EDS3 CSF 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/K162437
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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