510(k) · Cleared
ClearedNeurorecovery Ventricular Catheter & Main Valve Assembly Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurorecovery, Inc. · GWM Device, Monitoring, Intracranial Pressure
Cleared on Oct 31, 2002 as substantially equivalent to K902257 (Codman & Shurtleff, Inc., 1990) and 1 other predicate after an 84-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- Oct 31, 2002
- Review
- 84 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K864676 (1986). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK864676 Heyer-Schulte Hermetic External CSF Drain. SystemAmerican V. Mueller · 1986
- 1 generation backK972994 External CSF Drainage Management SystemsIntegra Neurocare, LLC · 1997
- This deviceK022638 Neurorecovery Ventricular Catheter & Main Valve Assembly KitNeurorecovery, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864676 | Heyer-Schulte Hermetic External CSF Drain. System | American V. Mueller | 1986 | — |
| −1 | K972994 | External CSF Drainage Management Systems | Integra Neurocare, LLC | 1997 | — |
| 0 (this device) | K022638 | Neurorecovery Ventricular Catheter & Main Valve Assembly Kit | Neurorecovery, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 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.
Planning a device in GWM? 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 GWM device
- #1 K252241 Pressio 3 Multi-parameter Neuromonitoring Systemscore 12.9 · 7 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 |
|---|---|---|---|
| * | K902257 | Codman* External Drainage System II (Eds-II)Summary page 1…ing Accessories (2 1 CFR 882.1620; ProCode: GWM) have been classified as Class I1 devices. 4. PREDICATE DEVICES Codnian EDS I1 (K902257) Johnson & Johnson Professional, Inc. 0 Heyer-Schulte NeuroCare External Drainage Management System (K972994)… | 1990 |
| * | K972994 | External CSF Drainage Management SystemsSummary page 1…DEVICES Codnian EDS I1 (K902257) Johnson & Johnson Professional, Inc. 0 Heyer-Schulte NeuroCare External Drainage Management System (K972994) [now believed to be MiiiiTon. CSF Drainage Sjistems tnarketed by Integra L $eSciences J Neurorccover… | 1997 |
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 3 companies; a new generation was cleared every 10.8 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K902257.
How does its category compare?
All GWM devicesGWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GWM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWM
30in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWM
3in 2025
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · GWM
441in 2025
MAUDE reports naming product code GWM, 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 | 2 | — | 0 | 126 |
| 2008 | 2 | — | 1 | 105 |
| 2009 | 1 | — | 0 | 117 |
| 2010 | 2 | — | 9 | 104 |
| 2011 | 3 | 123 | 6 | 184 |
| 2012 | 4 | 100 | 1 | 151 |
| 2013 | 2 | — | 12 | 120 |
| 2014 | 2 | — | 2 | 360 |
| 2015 | 0 | — | 0 | 486 |
| 2016 | 3 | 192 | 0 | 419 |
| 2017 | 3 | 37 | 0 | 445 |
| 2018 | 1 | — | 0 | 302 |
| 2019 | 2 | — | 1 | 260 |
| 2020 | 3 | 30 | 0 | 268 |
| 2021 | 2 | — | 0 | 211 |
| 2022 | 0 | — | 0 | 424 |
| 2023 | 0 | — | 1 (1) | 744 |
| 2024 | 2 | — | 4 (2) | 641 |
| 2025 | 1 | — | 3 | 441 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Neurorecoverym, Inc., Neurorecoverym Ventricular Catheter & Main Valve Assembly Kit is designed to be used for external monitoring of intracranial pressure (ICP), cerebrospinal fluid (CSF) sampling, and CSF drainage from the lateral ventricles of the human brain. The Main Valve Assembly is designed to facilitate the monitoring, sampling, clearing, and drainage function in an aseptic manner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022638 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022638: Neurorecovery Ventricular Catheter & Main Valve Assembly Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022638
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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