510(k) · Cleared
ClearedSmart External Drain (SED) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aqueduct Critical Care, Inc. · JXG Shunt, Central Nervous System And Components
Cleared on Nov 14, 2017 as substantially equivalent to K171586 (Aqueduct Critical Care, Inc., 2017) and 1 other predicate after a 62-day review. Its family tree reaches back 4 generations to 1990. 1 of the 8 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Nov 14, 2017
- Review
- 62 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K902257 (1990). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK902257 Codman* External Drainage System II (Eds-II)Codman & Shurtleff, Inc. · 1990
- 3 generations backK984053 Becker External Drainage and Monitoring SystemMedtronic PS Medical · 1999 · Recalled (Class I)
- 2 generations backK161605 Smart External Drain (SED) SystemAqueduct Critical Care, Inc. · 2016
- 1 generation backK171586 Smart External Drain (SED) SystemAqueduct Critical Care, Inc. · 2017
- This deviceK172759 Smart External Drain (SED) SystemAqueduct Critical Care, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK251598 IntellidropBrainspace, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK181301 Smart External Drain (SED) SystemAqueduct Critical Care, Inc. · 2018
Class I recalls in this family
- K984053 Becker External Drainage and Monitoring Systemdirect predicate · 1999
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K902257 | Codman* External Drainage System II (Eds-II) | Codman & Shurtleff, Inc. | 1990 | — |
| −3 | K984053 | Becker External Drainage and Monitoring System | Medtronic PS Medical | 1999 | Class I |
| −2 | K161605 | Smart External Drain (SED) System | Aqueduct Critical Care, Inc. | 2016 | — |
| −1 | K171586 | Smart External Drain (SED) System | Aqueduct Critical Care, Inc. | 2017 | — |
| 0 (this device) | K172759 | Smart External Drain (SED) System | Aqueduct Critical Care, Inc. | 2017 | — |
| +1 | K251598 | Intellidrop | Brainspace, Inc. | 2025 | — |
| +1 | K181301 | Smart External Drain (SED) System | Aqueduct Critical Care, Inc. | 2018 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K171586 | Smart External Drain (SED) SystemSummary page 6…c. cites the following as the predicate devices. Primary Predicate Smart External Drain (SED) System K171586 Secondary Predicate Duet External Drainage and Monitoring System K984053… | 2017 |
| * | K984053 | Becker External Drainage and Monitoring SystemSummary page 6…K171586 Secondary Predicate Duet External Drainage and Monitoring System K984053 Table 1 below provides a summary of the technological characteristics of the Modified SED System in comparison to the predicate… | 1999 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · Direct predicate · ◆ on the line of descent in FIG. 15 Class I recalls
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 8.5 years on median.
- 1 of the 5 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K251598 (Brainspace, Inc., 2025) 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. 2017, 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?
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. Monitoring of intracranial pressure (ICP) is indicated in selected patients with: • Severe head injury •…
Read the full statement (112 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.
Monitoring of intracranial pressure (ICP) is indicated in selected patients with:
• Severe head injury
• Subarachnoid hemorrhage graded III, IV, or V preoperatively
• Reye's syndrome or similar encephalopathies
• Hydrocephalus
• Intracranial hemorrhage
• 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 as stated in the FDA summary.
https://510kreport.com/device/K172759 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172759: Smart External Drain (SED) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172759
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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