510(k) · Cleared
ClearedHolter in-Line Shunt Filter, Holter Cerebral Catheter Reservoir, Accu-Flo Connectors; Accu-Flo Three Way Connector; Codm
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 Feb 18, 2011 as substantially equivalent to K944222 (Johnson & Johnson Professionals, Inc., 1995) and 1 other predicate after a 136-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Feb 18, 2011
- Review
- 136 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K944222 (1995). No later device cites it as a predicate yet.
- Root · 2 generations backK944222 Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc. · 1995
- 1 generation backK973774 Codman Hakim Micro Precision ValveJohnson & Johnson Professionals, Inc. · 1997
- This deviceK102961 Holter in-Line Shunt Filter, Holter Cerebral Catheter Reservoir…Codman & Shurtleff, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944222 | Codman-Medos Valve Shunt System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −1 | K973774 | Codman Hakim Micro Precision Valve | Johnson & Johnson Professionals, Inc. | 1997 | — |
| 0 (this device) | K102961 | Holter in-Line Shunt Filter, Holter Cerebral Catheter Reservoir, Accu-Flo… | Codman & Shurtleff, Inc. | 2011 | — |
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? (12)
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 |
|---|---|---|---|
| * | K944222 | Codman-Medos Valve Shunt SystemSummary page 2…Reservoir, LeRoy Design Preamendment - CODMAN® ACCU-FLO® Straight Connectors K944222 - CODMAN® MEDOS® Straight Connector Preamendment - CODMAN® HOLTER® Type A Fixation and… | 1995 |
| * | K973774 | Codman Hakim Micro Precision ValveSummary page 2…K944222 - CODMAN® MEDOS® Right Angle Connector Preamendment - CODMAN® HOLTER® SELKER Reservoir K973774 - CODMAN® ACCU-FLO® Straight Connector, Plastic… | 1997 |
| * | — | CODMAN® HOLTER® In-Line Shunt Filter, Hoffman Design Named without a submission number | |
| * | — | CODMAN® HOLTER® Cerebral Catheter-Reservoir, LeRoy Design Named without a submission number | |
| * | — | CODMAN® ACCU-FLO® Straight Connectors Named without a submission number | |
| * | — | CODMAN® HOLTER® Type A Fixation and Joining Connector Named without a submission number | |
| * | — | CODMAN® HOLTER® Type B Fixation and Joining Connector Named without a submission number | |
| * | — | CODMAN® ACCU-FLO® Connector, Three Way Named without a submission number | |
| * | — | CODMAN® HOLTER® RICKHAM® Reservoir Named without a submission number | |
| * | — | CODMAN® HOLTER® SALMON-RICKHAM® Reservoir Named without a submission number | |
| * | — | CODMAN® ACCU-FLO® Right Angle Connectors Named without a submission number | |
| * | — | CODMAN® HOLTER® SELKER Reservoir Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 13.1 years on median.
- None of the 2 ancestors has a recall.
- 7 other devices also cite its predicate K944222.
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. 2011, 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?
The Codman-Medos Connector is for use in the treatment of hydrocepha/us as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated. The Type A Fixation and Joining Connector is indicated for use in the joining and fixation of 1.2 mm nominal /.D. silicone rubber tubing with nonabsorbable sutures in a surgical application. The Type B Fixation and Joining Connector is indicated for use in the joining and fixation of…
Read the full statement (344 words)
The Codman-Medos Connector is for use in the treatment of hydrocepha/us as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
The Type A Fixation and Joining Connector is indicated for use in the joining and fixation of 1.2 mm nominal /.D. silicone rubber tubing with nonabsorbable sutures in a surgical application.
The Type B Fixation and Joining Connector is indicated for use in the joining and fixation of 0.8 mm nominal l.D. silicone rubber tubing to 1.2 mm nominal /.D. silicone rubber tubing, and specifically, catalog no. 82-1672, with nonabsorbable sutures in a surgical application.
The Ventriculostomy Reservoir Set is indicated for use to gain access to the cerebral ventricles or other intracranial cavities for the purpose of diagnostic studies or therapeutic drug administration with or without a shunting device. When used with the shunting device, the ventriculostomy reservoir is also indicated for use as the proximal fluid pathway.
The ACCU-FLO Three Way Connector can be utilized as a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into the right atrium of the heart or the peritoneal cavity, providing they are used in the joining and fixation of approximately 1.3 mm nominal I.D. silicone rubber tubing with nonabsorbable sutures in a surgical application.
The ACCU-FLO Connectors can be utilized as a component in systems designed to shunt cerebrospinal fluid from the lateral ventricles into the right atrium of the heart or the peritoneal cavity, providing they are used in the joining and fixation of approximately 1.3mm nominal /.D. silicone rubber tubing with nonabsorbable sutures in a surgical application.
The Cerebral Catheter-Reservoir is indicated for use as a component of a shunting system to gain access to the cerebral ventricles or other intracranial cavities for the purpose of diagnostic studies, therapeutic drug administration, or the diversion of fluid.
The In-Line Shunt Filter is indicated for use to filter particles that are larger than approximately 3.9 microns when neoplasrn is suspected and when shunting is the procedure of choice in the treatment of hydrocephalus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102961: Holter in-Line Shunt Filter, Holter Cerebral Catheter Reservoir, Accu-Flo Connectors; Accu-Flo Three Way Connector; Codm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102961
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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