510(k) · Cleared

Cleared

Codman* External Drainage System II (Eds-II)

K902257510(k) TraditionalCleared Jul 19, 199059-day reviewClass II21 CFR 882.5550

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Codman & Shurtleff, Inc. · JXG Shunt, Central Nervous System And Components

Cleared on Jul 19, 1990 after a 59-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 22 devices in its family, counting itself, have a Class I recall. 21 later devices descend from it.

Decided: Jul 19, 1990
Review: 59 days
Class: Class II
Product code: JXG
Recalls: None
Predicates: 0

21 later devices descend from it, 4 citing it directly. 2 of the 22 devices in this family, counting this one, have a Class I recall.

This deviceK902257 Codman* External Drainage System II (Eds-II)Codman & Shurtleff, Inc. · 1990
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 21 descendants. See all descendants

Descendants cleared per year

1998high 3 (2017) · low 0 (2001)2026

Class I recalls in this family

K984053 Becker External Drainage and Monitoring Systemcites it directly · 1999
K200456 Becker External Drainage and Monitoring System2 generations on · 2020

Most influential descendants

Showing 5 of 21 · 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)	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
+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
2002	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

FIG. 1 — Lineage of K902257, 1990–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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? (21)

See all 21

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K984053	Becker External Drainage and Monitoring System Class I	Medtronic PS Medical	1999	13
K061568	Codman Eds 3 CSF External Drainage System, Models 82-1730, 82-1731, 82-1732, 82-1733…	Codman & Shurtleff, Inc.	2006	4
K022638	Neurorecovery Ventricular Catheter & Main Valve Assembly Kit	Neurorecovery, Inc.	2002	0
K981046	Medtronic PS Medical External Drainage and Monitoring (Edm) Ventricular Catheter, 20CM…	Medtronic PS Medical	1998	0

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 devices

JXG 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

2007high 8 (2025) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JXG

255in 2025

2007high 276 (2015) · low 30 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JXG

3in 2024

2007high 30 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JXG

1,198in 2025

2007high 1,484 (2018) · low 629 (2009)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/K902257 · printed Nov 6, 2026

Cite this page

510(k) Report. “K902257: 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/K902257

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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