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 Oct 27, 2016 as substantially equivalent to K984053 (Medtronic PS Medical, 1999) after a 139-day review. Its family tree reaches back 2 generations to 1990. 1 of the 8 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Oct 27, 2016
- Review
- 139 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K902257 (1990). 3 ancestors in all. 4 later devices descend from it, 1 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK902257 Codman* External Drainage System II (Eds-II)Codman & Shurtleff, Inc. · 1990
- 1 generation backK984053 Becker External Drainage and Monitoring SystemMedtronic PS Medical · 1999 · Recalled (Class I)
- This deviceK161605 Smart External Drain (SED) SystemAqueduct Critical Care, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK171586 Smart External Drain (SED) SystemAqueduct Critical Care, Inc. · 2017
- Descendant · 2 generations on · 2 of its ownK172759 Smart External Drain (SED) SystemAqueduct Critical Care, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK251598 IntellidropBrainspace, Inc. · 2025
- Descendant · 3 generations on · 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 4 of 4 · See all- K171586Smart External Drain (SED) SystemAqueduct Critical Care, Inc. · 2017 · cites it directly3descendants
- K172759Smart External Drain (SED) SystemAqueduct Critical Care, Inc. · 2017 · 2 generations on2descendants
- K251598IntellidropBrainspace, Inc. · 2025 · 3 generations on0descendants
- K181301Smart External Drain (SED) SystemAqueduct Critical Care, Inc. · 2018 · 3 generations on0descendants
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 | K984053 | Becker External Drainage and Monitoring System | Medtronic PS Medical | 1999 | Class I |
| 0 (this device) | K161605 | Smart External Drain (SED) System | Aqueduct Critical Care, Inc. | 2016 | — |
| +1 | K171586 | Smart External Drain (SED) System | Aqueduct Critical Care, Inc. | 2017 | — |
| +2 | K172759 | Smart External Drain (SED) System | Aqueduct Critical Care, Inc. | 2017 | — |
| +3 | K251598 | Intellidrop | Brainspace, Inc. | 2025 | — |
| +3 | 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 |
|---|---|---|
| 2017 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K984053 | Becker External Drainage and Monitoring SystemSummary page 6…t Critical Care, Inc. cites the following as the predicate device. Predicate Device Duet External Drainage and Monitoring System K984053 Table 1 below provides a summary of the technological characteristics of the SED System in comparison to the predicate device.… | 1999 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171586 | Smart External Drain (SED) System | 2017 | 3 |
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 26 years and passes through 3 companies; a new generation was cleared every 17.7 years on median.
- 1 of the 3 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K171586 (Aqueduct Critical Care, Inc., 2017) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K984053.
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?
Draining and monitoring of CSF flow from the lateral ventricles 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…
Read the full statement (108 words)
Draining and monitoring of CSF flow from the lateral ventricles 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/K161605 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161605: 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/K161605
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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