510(k) Report

510(k) · Cleared

Cleared

Polaris Pressure Adjustable Valve System, Models SPV-140, SPV-300, SPV-400

K042481510(k) TraditionalCleared Dec 14, 200492-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

Sophysa SA · JXG Shunt, Central Nervous System And Components

Cleared on Dec 14, 2004 as substantially equivalent to K031097 (Sophysa SA, 2004) after a 92-day review. Its family tree reaches back 5 generations to 1995. 7 later devices descend from it.

Decided
Dec 14, 2004
Review
92 days
Class
Class II
Product code
JXG
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K944222 (1995). 6 ancestors in all, the oldest K861377 (1986). 7 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1986: 1 other ancestor2007: 1 descendant cleared2015: 1 descendant cleared2017: 1 descendant cleared2010: 2 descendants cleared2012: 1 descendant cleared2019: 1 descendant clearedK944222 · Codman-Medos Valve Shunt System · Johnson & Johnson Professionals, Inc. · 1995K974739 · Hakim Programmable Valve System · Johnson & Johnson Professionals, Inc. · 1998K992465 · Sophy SU8 Pressure Adjustable Valve · Sophysa SA · 2000K013488 · Sophy Pressure Adjustable Valve System Model SM8 · Sophysa SA · 2002K031097 · Polaris Pressure Adjustable Valve System Modes SPV, Spva, SPVB · Sophysa SA · 20041990200020102020
Other ancestors, by generationDescendants, by generation 4 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 5 descendants3 generations forward: 1 descendant K031097 · Polaris Pressure Adjustable Valve System Modes SPV, Spva, SPVB · Sophysa SA · 2004K013488 · Sophy Pressure Adjustable Valve System Model SM8 · Sophysa SA · 2002K992465 · Sophy SU8 Pressure Adjustable Valve · Sophysa SA · 2000K974739 · Hakim Programmable Valve System · Johnson & Johnson Professionals, Inc. · 1998K944222 · Codman-Medos Valve Shunt System · Johnson & Johnson Professionals, Inc. · 1995−50
  1. Root · 5 generations backK944222 Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc. · 1995
  2. 4 generations backK974739 Hakim Programmable Valve SystemJohnson & Johnson Professionals, Inc. · 1998
  3. 3 generations backK992465 Sophy SU8 Pressure Adjustable ValveSophysa SA · 2000
  4. 2 generations backK013488 Sophy Pressure Adjustable Valve System Model SM8Sophysa SA · 2002
  5. 1 generation backK031097 Polaris Pressure Adjustable Valve System Modes SPV, Spva, SPVBSophysa SA · 2004
  6. This deviceK042481 Polaris Pressure Adjustable Valve System, Models SPV-140, SPV-300…Sophysa SA · 2004
  7. Descendant · cites it directly · 6 of its ownK062009 Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451TAesculap, Inc. · 2007
  8. Descendant · 2 generations on · 4 of its ownK103003 Aesculap- Meithke Progav Programmable Shunt SystemAesculap, Inc. · 2010 · Recalled
  9. Descendant · 2 generations on · 2 of its ownK141687 Aesculap - Meithke Progav 2.0 Adjustable Shunt SystemAesculap, Inc. · 2015
  10. Descendant · 2 generations on · 2 of its ownK120559 Aesculap-Meithke Prosa Adjustable Shunt SystemAesculap, Inc. · 2012 · Recalled
  11. Descendant · 2 generations on · 1 of its ownK161853 proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt…Aesculap, Inc. · 2017 · Recalled

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2007: 12010: 22012: 12015: 12017: 12019: 1
2007high 2 (2010) · low 0 (2008)2026

Most influential descendants

Showing 5 of 7 · See all
  • K062009Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451TAesculap, Inc. · 2007 · cites it directly6descendants
  • K103003Aesculap- Meithke Progav Programmable Shunt SystemAesculap, Inc. · 2010 · 2 generations on4descendants
  • K141687Aesculap - Meithke Progav 2.0 Adjustable Shunt SystemAesculap, Inc. · 2015 · 2 generations on2descendants
  • K120559Aesculap-Meithke Prosa Adjustable Shunt SystemAesculap, Inc. · 2012 · 2 generations on2descendants
  • K161853proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable…Aesculap, Inc. · 2017 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K944222Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc.1995—
−4K974739Hakim Programmable Valve SystemJohnson & Johnson Professionals, Inc.1998—
−3K992465Sophy SU8 Pressure Adjustable ValveSophysa SA2000—
−2K013488Sophy Pressure Adjustable Valve System Model SM8Sophysa SA2002—
−1K031097Polaris Pressure Adjustable Valve System Modes SPV, Spva, SPVBSophysa SA2004—
0 (this device)K042481Polaris Pressure Adjustable Valve System, Models SPV-140, SPV-300, SPV-400Sophysa SA2004—
+1K062009Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451TAesculap, Inc.2007—
+2K103003Aesculap- Meithke Progav Programmable Shunt SystemAesculap, Inc.20105
+2K141687Aesculap - Meithke Progav 2.0 Adjustable Shunt SystemAesculap, Inc.2015—
+2K120559Aesculap-Meithke Prosa Adjustable Shunt SystemAesculap, Inc.20122
+2K161853proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA…Aesculap, Inc.20171

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201020
201210
201510
201710
201910
FIG. 1 — Lineage of K042481, 1995–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243531 Codman Libertís Shunt Catheter with Bactiseal…score 11.9 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K031097Polaris Pressure Adjustable Valve System Modes SPV, Spva, SPVB
Summary page 1
…ion of Predicate Device(s) The Polaris® Pressure Adjustable Valve models SPY-140, SPV-300, SPV-400 is substantially equivalent to the SOPHYSA Sophy® Polaris® SPV Valve (K031097) previously cleared and currently marketed. D. Device Description The Polaris® Pressure Adjustable Valve models SPV-140, SPV-3…
Sophysa SA2004—

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K062009Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451TAesculap, Inc.20076

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 9 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K062009 (Aesculap, Inc., 2007) has gone furthest, with 6 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

2007: 32008: 62009: 52010: 32011: 72012: 32013: 32015: 62016: 62017: 72018: 62019: 42020: 22021: 12022: 42023: 52024: 32025: 82026 (partial year): 2
2007high 8 (2025) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JXG

255in 2025

2007: 184 days median2008: 60 days median2009: 106 days median2010: 30 days median2011: 136 days median2012: 78 days median2013: 108 days median2015: 276 days median2016: 143 days median2017: 90 days median2018: 102 days median2019: 101 days median2022: 101 days median2023: 134 days median2024: 90 days median2025: 255 days median
2007high 276 (2015) · low 30 (2010)2026

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

Recalls per year · JXG

3in 2024

2008: 12009: 302011: 52012: 12013: 142014: 62017: 12020: 82023: 22024: 32026 (partial year): 1
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

2007: 6492008: 6302009: 6292010: 8122011: 7872012: 9772013: 1,0042014: 1,2512015: 9842016: 1,0912017: 1,3352018: 1,4842019: 1,2952020: 1,2062021: 1,4672022: 1,3292023: 1,2212024: 1,2142025: 1,198
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200731840649
20086601630
2009510630629
20103300812
201171365787
20123781977
20133108141,004
20140—61,251
201562760984
2016614301,091
201779011,335
2018610201,484
2019410101,295
20202—81,206
20211—01,467
2022410101,329
2023513421,221
202439031,214
2025825501,198
20262—1—

What is it indicated for?

To drain cerebrospinal fluid (CSF) for the management of hydrocephalus.

Indications for use as stated in the FDA summary.

More from Sophysa SA

9 FDA decisions under this applicant name. See the company

  • K162108Pressio 2 ICP Monitoring SystemSophysa SA · 20173 recalls
  • K141227Polaris Pressure Adjustable Valve System/Polaris Adjustable Valve with SiphonxSophysa SA · 2015
  • K091328Siphonx Gravitational Antisiphon DeviceSophysa SA · 2010
  • K090342Polaris Pressure Adjustable Valve, Models SPV, Spva, SPVB, SPV-140, SPV-300, SPV-400Sophysa SA · 2009
  • K062584Pressio Icp Monitoring SystemSophysa SA · 20072 recalls

Recent decisions in JXG

The JXG category page

  • K260044Ventricular Catheters, Thomale CatheterAesculap, Inc. · 2026
  • K261004Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON…Integra Lifesciences Production Corporation · 2026
  • K251598IntellidropBrainspace, Inc. · 2025
  • K250636Sophy Mini Monopressure Valve (SM1)Sophysa · 2025
  • K252514Evac-MriPhasor Health, LLC · 2025

https://510kreport.com/device/K042481 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042481: Polaris Pressure Adjustable Valve System, Models SPV-140, SPV-300, SPV-400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042481

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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