# Spes Medica Srl

- Location (FDA's records): Battipaglia, IT
- FDA decisions: 9 (2009–2022): 9 510(k) clearances
- Product codes: GYB (3), ETN (2), GYC (1), IKT (1), GXZ (1), GXY (1)
- Predicates its devices cite: 26 (2 its own); citations of its devices by later devices: 8 (2 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Rhythmlink International, LLC: 3 (https://510kreport.com/company/rhythmlink-international)
- Technomed Europe: 2 (https://510kreport.com/company/technomed-europe)
- Medicotest A/S: 2 (https://510kreport.com/company/medicotest-a-s)
- Ambu A/S: 2 (https://510kreport.com/company/ambu-a-s)
- Medelec, Inc. D.B.A. Teca Corp.: 2 (https://510kreport.com/company/medelec-dba-teca)
- Ad-Tech Medical Instrument Corp: 1 (https://510kreport.com/company/ad-tech-medical-instrument)
- Neurovision Medical Products, Inc.: 1 (https://510kreport.com/company/neurovision-medical-products)
- Xian Friendship Medical Electronics Co., Ltd.: 1 (https://510kreport.com/company/xian-friendship-medical-electronics)

## Firms that cite its devices most
- Bionen S.A.S.: 1 (https://510kreport.com/company/bionen)
- Technomed Europe: 1 (https://510kreport.com/company/technomed-europe)
- Somnomedics GmbH: 1 (https://510kreport.com/company/somnomedics)
- Ad-Tech Medical Instrument Corp: 1 (https://510kreport.com/company/ad-tech-medical-instrument)
- Guangzhou Xinbo Electronic Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-xinbo-electronic)
- Wuhan Greentek Pty, Ltd.: 1 (https://510kreport.com/company/wuhan-greentek)

## Its most-cited devices
- K190050: Tech Dots - Adhesive and conductive gel (2019), cited by 3
- K192606: SAC2 - Electrode Cream (2020), cited by 2
- K133348: Stim Probe (2014), cited by 1
- K091410: Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot, (2009), cited by 1
- K093373: Laryngeal Surface Electrode (2010), cited by 1

## Recent decisions
- K211954: Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid (Nov 10, 2022)
- K212326: AC Cream - Conductive paste (Dec 1, 2021)
- K192606: SAC2 - Electrode Cream (Jan 17, 2020)
- K192603: Spes Medica Subdermal Needle Electrodes (Nov 22, 2019)
- K190050: Tech Dots - Adhesive and conductive gel (Jul 19, 2019)
- K133348: Stim Probe (Nov 21, 2014)
- K120494: Disposable Adhesive Surface Electrode (Jun 11, 2012)
- K093373: Laryngeal Surface Electrode (Aug 24, 2010)

Source page: https://510kreport.com/company/spes-medica