510(k) Report

FDA applicant

Medtronic Neurosurgery

Goleta, CA28 decisions2001–202511 recalls

FDA records 28 decisions for Medtronic Neurosurgery (Goleta, CA) from 2001 to 2025: 27 510(k) clearances and 1 De Novo grant. Most are in product codes JXG (Shunt, Central Nervous System And Components) and GXQ (Dura Substitute). Since 2016 its 510(k)s took a median of 136 days from receipt to decision, against 123 for FDA’s reviews in the same codes and years. Its devices cite 64 predicates, 25 of them its own earlier devices. 11 recalls are linked to its devices, 1 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Medtronic Neurosurgery’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007: 12008: 32009: 12011: 12013: 12014: 12016: 22018: 12021: 12024: 12025: 1
2007high 3 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2023

2013: 12017: 3, 1 Class I2018: 12020: 32021: 22023: 1
2007high 3 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medtronic Neurosurgery by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medtronic Neurosurgery’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • JXGShunt, Central Nervous System And Components18decisions
  • GXQDura Substitute4decisions
  • PCBExternal Cerebrospinal Fluid (Csf) Diversion2decisions
  • GXNPlate, Cranioplasty, Preformed, Non-Alterable1decision
  • FZPClip, Implantable1decision
  • HWCScrew, Fixation, Bone1decision

Also: HBO (1).

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 136 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 123 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 64 predicates; 25 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 36 times; 25 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K042465PS Medical Strata II ValveMedtronic Neurosurgery · 20046cite it
  • K033850Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without BioglideMedtronic Neurosurgery · 20046cite it
  • K040943Medtronic PS Medical Strata ValveMedtronic Neurosurgery · 20045cite it
  • K041000Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 20044cite it
  • K052211Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 20053cite it
  • K161370Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 20162cite it

What has FDA decided for it lately?

  • K243676Duet External Drainage and Monitoring System (EDMS)Medtronic Neurosurgery · 2025
  • K242034Duet External Drainage and Monitoring System (EDMS)Medtronic Neurosurgery · 2024
  • K212641StrataMR II Valves and ShuntsMedtronic Neurosurgery · 2021
  • K181622StrataMR guider toolMedtronic Neurosurgery · 2018
  • K161370Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 20161 recall
  • K152700StrataMR Valves and ShuntsMedtronic Neurosurgery · 20161 Class I recall
  • DEN120017Medtronic DUET External Drainage and Monitoring SystemMedtronic Neurosurgery · 2014
  • K123524Medtronic Strata NSC Lumboperitoneal Valve and Shunt SystemMedtronic Neurosurgery · 20131 recall

All 28 as Medtronic Neurosurgery →

What has been recalled?

11 recalls linked to its devices; the latest:

  • K161370Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA…Jun 13, 2023Class II
  • K042465Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following…Jan 11, 2021Class II
  • K033850Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and…Jan 11, 2021Class II
  • K110560Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in…Dec 8, 2020Class II
  • K110560Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only. Used in…Dec 8, 2020Class II
  • K110560Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only. Used in…Dec 8, 2020Class II