# Gilero, LLC

- Location (FDA's records): Morrisville, NC
- FDA decisions: 2 (2021–2023): 2 510(k) clearances
- Product codes: MRZ (1), KPE (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 2 (0 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
- Smiths Medical MD, Inc.: 1 (https://510kreport.com/company/smiths-medical-md)
- Valmed Corp.: 1 (https://510kreport.com/company/valmed)

## Firms that cite its devices most
- Icu Medical, Inc.: 1 (https://510kreport.com/company/icu-medical)
- Technoflex Sas.: 1 (https://510kreport.com/company/technoflex)

## Its most-cited devices
- K201936: SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL (2021), cited by 2

## Recent decisions
- K230718: UTC 3mL Medication Cartridge (Jun 15, 2023)
- K201936: SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL (May 6, 2021)

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