# Eurosets S.R.L

- Location (FDA's records): Medolla, IT
- FDA decisions: 7 (2011–2026): 7 510(k) clearances
- Product codes: DTZ (7)
- 510(k) review time since 2016: median 239 days, against 336 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 12 (3 its own); citations of its devices by later devices: 4 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sorin Group Italia S.R.L.: 7 (https://510kreport.com/company/sorin-group-italia)
- Terumo Cardiovascular Systems Corp.: 1 (https://510kreport.com/company/terumo-cardiovascular-systems)
- Dideco S.P.A.: 1 (https://510kreport.com/company/dideco)

## Firms that cite its devices most
- Spectrum Medical, Ltd.: 1 (https://510kreport.com/company/spectrum-medical)

## Its most-cited devices
- K141492: Advanced Membrance Gas Exchange PMP Sterile (a.M.G PMP Sterile) (2015), cited by 2
- K102109: Advanced Membrane Gas Exchange (Amg), Amg Oxygenaling Module, Amg Venous Cardiotomy Resevoir 4500 Model EU5011, EU5012 (2011), cited by 1
- K202206: AMG PMP Pediatric (2021), cited by 1

## Recent decisions
- K261438: HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) (Sep 14, 2026)
- K250821: Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073) (Dec 12, 2025)
- K242503: Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) (Nov 24, 2025)
- K202510: AMG PMP Infant (Dec 10, 2021)
- K202206: AMG PMP Pediatric (Apr 1, 2021)
- K141492: Advanced Membrance Gas Exchange PMP Sterile (a.M.G PMP Sterile) (Feb 6, 2015)
- K102109: Advanced Membrane Gas Exchange (Amg), Amg Oxygenaling Module, Amg Venous Cardiotomy Resevoir 4500 Model EU5011, EU5012 (Feb 15, 2011)

Source page: https://510kreport.com/company/eurosets