510(k) · Cleared
ClearedCodman External Drainage System II (Eds II)
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 Aug 16, 1991 after a 163-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 21 devices in its family, counting itself, have a Class I recall. 20 later devices descend from it.
- Decided
- Aug 16, 1991
- Review
- 163 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 3 citing it directly. 2 of the 21 devices in this family, counting this one, have a Class I recall.
- This deviceK910938 Codman External Drainage System II (Eds II)Codman & Shurtleff, Inc. · 1991
- Descendant · cites it directly · 13 of its ownK984053 Becker External Drainage and Monitoring SystemMedtronic PS Medical · 1999 · Recalled (Class I)
- Descendant · 2 generations on · 4 of its ownK171880 IRRAflow CNS SystemIrras, Inc. · 2018
- Descendant · 2 generations on · 4 of its ownK161605 Smart External Drain (SED) SystemAqueduct Critical Care, Inc. · 2016
- Descendant · cites it directly · 4 of its ownK061568 Codman Eds 3 CSF External Drainage System, Models 82-1730, 82-1731…Codman & Shurtleff, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 3 of its ownK192289 IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitIrras USA, Ltd. · 2019
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 20 · See all- K984053Becker External Drainage and Monitoring SystemMedtronic PS Medical · 1999 · cites it directly13descendants
- K171880IRRAflow CNS SystemIrras, Inc. · 2018 · 2 generations on4descendants
- K161605Smart External Drain (SED) SystemAqueduct Critical Care, Inc. · 2016 · 2 generations on4descendants
- K061568Codman Eds 3 CSF External Drainage System, Models 82-1730, 82-1731, 82-1732, 82-1733…Codman & Shurtleff, Inc. · 2006 · cites it directly4descendants
- K192289IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitIrras USA, Ltd. · 2019 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910938 | Codman External Drainage System II (Eds II) | Codman & Shurtleff, Inc. | 1991 | — |
| +1 | K984053 | Becker External Drainage and Monitoring System | Medtronic PS Medical | 1999 | Class I |
| +2 | K171880 | IRRAflow CNS System | Irras, Inc. | 2018 | — |
| +2 | K161605 | Smart External Drain (SED) System | Aqueduct Critical Care, Inc. | 2016 | — |
| +1 | K061568 | Codman Eds 3 CSF External Drainage System, Models 82-1730, 82-1731, 82-1732… | Codman & Shurtleff, Inc. | 2006 | 3 |
| +3 | K192289 | IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit | Irras USA, Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 1 |
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (20)
See all 203 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)
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 · Cites it directly · ◆ in the 1999 descendants bar of FIG. 15 Class I recalls
- K200456Becker External Drainage and Monitoring SystemMedtronic, Inc. · 2020 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K984053 (Medtronic PS Medical, 1999) has gone furthest, with 13 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.
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 | — |
https://510kreport.com/device/K910938 · printed Nov 6, 2026
Cite this page
510(k) Report. “K910938: Codman External Drainage System II (Eds II).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910938
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026