510(k) Report

510(k) · Cleared

Cleared

Subdural Evacuating Port System, Model 11-9901

K002970510(k) TraditionalCleared Dec 12, 200081-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

Medical Designs, LLC · JXG Shunt, Central Nervous System And Components

Cleared on Dec 12, 2000 after an 81-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Dec 12, 2000
Review
81 days
Class
Class II
Product code
JXG
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2025: 1 descendant cleared2024: 1 descendant cleared200020052010201520202025
  1. This deviceK002970 Subdural Evacuating Port System, Model 11-9901Medical Designs, LLC · 2000
  2. Descendant · cites it directly · 2 of its ownK042359 Subdural Evacuating Port System Cranial Access Kit (Seps-CA)…Medical Designs, LLC · 2004 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK252514 Evac-MriPhasor Health, LLC · 2025
  4. Descendant · 2 generations on · 0 of its ownK241458 Borvo EVAC System (Ergo); Borvo EVAC System (Classic)Borvo Medical, Inc. · 2024

Most influential descendants

Showing 3 of 3 · See all
  • K042359Subdural Evacuating Port System Cranial Access Kit (Seps-CA), (Seps-Cal)…Medical Designs, LLC · 2004 · cites it directly2descendants
  • K252514Evac-MriPhasor Health, LLC · 2025 · 2 generations on0descendants
  • K241458Borvo EVAC System (Ergo); Borvo EVAC System (Classic)Borvo Medical, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002970Subdural Evacuating Port System, Model 11-9901Medical Designs, LLC2000—
+1K042359Subdural Evacuating Port System Cranial Access Kit (Seps-CA), (Seps-Cal)…Medical Designs, LLC20041
+2K252514Evac-MriPhasor Health, LLC2025—
+2K241458Borvo EVAC System (Ergo); Borvo EVAC System (Classic)Borvo Medical, Inc.2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
202410
202510
FIG. 1 — Lineage of K002970, 2000–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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.

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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K042359Subdural Evacuating Port System Cranial Access Kit (Seps-CA), (Seps-Cal)…Medical Designs, LLC20042

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?

  • Of its descendants, K042359 (Medical Designs, LLC, 2004) has gone furthest, with 2 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—

More from Medical Designs, LLC

7 FDA decisions under this applicant name. See the company

  • K182352SP-LINK™ SystemMedical Designs, LLC · 2018
  • K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC · 2018
  • K143688Asfora Anterior Cervical Plate SystemMedical Designs, LLC · 2015
  • K112648Asfora Bullet CageMedical Designs, LLC · 2012
  • K090048Asfora Bullet Cage SystemMedical Designs, LLC · 2009

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/K002970 · printed Nov 5, 2026

Cite this page

510(k) Report. “K002970: Subdural Evacuating Port System, Model 11-9901.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002970

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026