510(k) Report

FDA applicant

Spes Medica Srl

Battipaglia, IT9 decisions2009–20223 recalls

FDA records 9 decisions for Spes Medica Srl (Battipaglia, IT) from 2009 to 2022: 9 510(k) clearances. Most are in product codes GYB (Media, Electroconductive) and ETN (Stimulator, Nerve). Its devices cite 26 predicates, 2 of them its own earlier devices. 3 recalls are linked to its devices.

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 Spes Medica Srl’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2009: 12010: 12012: 12014: 12019: 22020: 12021: 12022: 1
2009high 2 (2019) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

3in 2021

2021: 3
2009high 3 (2021) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Spes Medica Srl by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Spes Medica Srl’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?

  • GYBMedia, Electroconductive3decisions
  • ETNStimulator, Nerve2decisions
  • GYCElectrode, Cortical1decision
  • IKTElectrode, Needle, Diagnostic Electromyograph1decision
  • GXZElectrode, Needle1decision
  • GXYElectrode, Cutaneous1decision

Whose devices does it build on?

Its devices cite 26 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 2 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.

  • K190050Tech Dots - Adhesive and conductive gelSpes Medica Srl · 20193cite it
  • K192606SAC2 - Electrode CreamSpes Medica Srl · 20202cite it
  • K133348Stim ProbeSpes Medica Srl · 20141cites it
  • K091410Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot,Spes Medica Srl · 20091cites it
  • K093373Laryngeal Surface ElectrodeSpes Medica Srl · 20101cites it

What has FDA decided for it lately?

  • K211954Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid…Spes Medica Srl · 2022
  • K212326AC Cream - Conductive pasteSpes Medica Srl · 2021
  • K192606SAC2 - Electrode CreamSpes Medica Srl · 2020
  • K192603Spes Medica Subdermal Needle ElectrodesSpes Medica Srl · 2019
  • K190050Tech Dots - Adhesive and conductive gelSpes Medica Srl · 2019
  • K133348Stim ProbeSpes Medica Srl · 20141 recall
  • K120494Disposable Adhesive Surface ElectrodeSpes Medica Srl · 2012
  • K093373Laryngeal Surface ElectrodeSpes Medica Srl · 20102 recalls

All 9 as Spes Medica Srl →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K133348Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during…Apr 8, 2021Class II
  • K093373Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference…Apr 8, 2021Class II
  • K093373Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference…Apr 8, 2021Class II