510(k) Report

510(k) · Cleared

Cleared

Sophy Pressure Adjustable Valve System Model SM8

K013488510(k) TraditionalCleared Mar 27, 2002159-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 Mar 27, 2002 as substantially equivalent to K992465 (Sophysa SA, 2000) after a 159-day review. Its family tree reaches back 3 generations to 1995. 9 later devices descend from it.

Decided
Mar 27, 2002
Review
159 days
Class
Class II
Product code
JXG
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K944222 (1995). 4 ancestors in all, the oldest K861377 (1986). 9 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1986: 1 other ancestor2004: 2 descendants cleared2007: 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 · 20001990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 5 descendants5 generations forward: 1 descendant K992465 · 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. · 19950+5
  1. Root · 3 generations backK944222 Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc. · 1995
  2. 2 generations backK974739 Hakim Programmable Valve SystemJohnson & Johnson Professionals, Inc. · 1998
  3. 1 generation backK992465 Sophy SU8 Pressure Adjustable ValveSophysa SA · 2000
  4. This deviceK013488 Sophy Pressure Adjustable Valve System Model SM8Sophysa SA · 2002
  5. Descendant · cites it directly · 8 of its ownK031097 Polaris Pressure Adjustable Valve System Modes SPV, Spva, SPVBSophysa SA · 2004
  6. Descendant · 2 generations on · 7 of its ownK042481 Polaris Pressure Adjustable Valve System, Models SPV-140, SPV-300…Sophysa SA · 2004
  7. Descendant · 3 generations on · 6 of its ownK062009 Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451TAesculap, Inc. · 2007
  8. Descendant · 4 generations on · 4 of its ownK103003 Aesculap- Meithke Progav Programmable Shunt SystemAesculap, Inc. · 2010 · Recalled
  9. Descendant · 4 generations on · 2 of its ownK141687 Aesculap - Meithke Progav 2.0 Adjustable Shunt SystemAesculap, Inc. · 2015

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2004: 22007: 12010: 22012: 12015: 12017: 12019: 1
2004high 2 (2004) · low 0 (2005)2026

Most influential descendants

Showing 5 of 9 · See all
  • K031097Polaris Pressure Adjustable Valve System Modes SPV, Spva, SPVBSophysa SA · 2004 · cites it directly8descendants
  • K042481Polaris Pressure Adjustable Valve System, Models SPV-140, SPV-300, SPV-400Sophysa SA · 2004 · 2 generations on7descendants
  • K062009Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451TAesculap, Inc. · 2007 · 3 generations on6descendants
  • K103003Aesculap- Meithke Progav Programmable Shunt SystemAesculap, Inc. · 2010 · 4 generations on4descendants
  • K141687Aesculap - Meithke Progav 2.0 Adjustable Shunt SystemAesculap, Inc. · 2015 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200710
201020
201210
201510
201710
201910
FIG. 1 — Lineage of K013488, 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
*K992465Sophy SU8 Pressure Adjustable Valve
Summary page 1
…Model SM8 Regulatory Class: Class Il by 21 CFR 882.5550 C. ldentification of Predicate Device(s) The Sophy® SMS8 is substantially equivalent to the SOPHYSA Sophy® SU8 (K992465) previously cleared and currently marketed. D. Device Description The Sophy® Pressure Adjustable Valve System SM8 is an implant…
Sophysa SA2000—

Also cleared against K992465: 1 other device →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K031097Polaris Pressure Adjustable Valve System Modes SPV, Spva, SPVBSophysa SA20048

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 7 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K031097 (Sophysa SA, 2004) has gone furthest, with 8 descendants of its own.
  • 1 other device also cites its predicate K992465.

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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K992465

1 other device cites the same predicate.

  • K012052Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical · 2002

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/K013488 · printed Nov 5, 2026

Cite this page

510(k) Report. “K013488: Sophy Pressure Adjustable Valve System Model SM8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013488

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026