# Copan Italia Spa

- Location (FDA's records): Brescia, IT
- FDA decisions: 8 (1997–2024): 8 510(k) clearances
- Product codes: JSM (5), JSL (2), QBD (1)
- 510(k) review time since 2016: median 344 days, against 271 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 10 (2 its own); citations of its devices by later devices: 9 (2 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
- Starplex Scientific, Inc.: 2 (https://510kreport.com/company/starplex-scientific)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 2 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)
- Copan Diagnostics, Inc.: 1 (https://510kreport.com/company/copan-diagnostics)
- Longhorn Vaccines and Diagnostics, LLC: 1 (https://510kreport.com/company/longhorn-vaccines-and-diagnostics)
- Bd: 1 (https://510kreport.com/company/bd)
- Merit Medical Systems, Inc.: 1 (https://510kreport.com/company/merit-medical-systems)

## Firms that cite its devices most
- Puritan Medical Products, LLC: 2 (https://510kreport.com/company/puritan-medical-products)
- Shenzhen Dakewe Bio-Engineering Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-dakewe-bio-engineering)
- Zhejiang Gongdong Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/zhejiang-gongdong-medical-technology)
- Copan Diagnostics, Inc.: 1 (https://510kreport.com/company/copan-diagnostics)
- Medical Wire & Equipment Company (Bath), Ltd.: 1 (https://510kreport.com/company/medical-wire-equipment-company-bath)
- Zhejiang Gene Science Co., Ltd.: 1 (https://510kreport.com/company/zhejiang-gene-science)

## Its most-cited devices
- K142094: Copan Fecalswab Collection, Transport and Preservation System (2015), cited by 3
- K972448: Copan Venturi Transystem Amies Medium Without Charcoal (1997), cited by 2
- K201849: eNAT molecular collection and preservation medium (2020), cited by 2
- K180052: UriSwab-Urine Collection, Transport and Preservation System (2018), cited by 2

## Recent decisions
- K232565: UriSponge™ (Oct 11, 2024)
- K232357: Copan Universal Transport Medium (UTM-RT) System (Apr 25, 2024)
- K220052: Copan FecalSwab Collection, Transport and Preservation System (Dec 16, 2022)
- K201849: eNAT molecular collection and preservation medium (Sep 17, 2020)
- K180052: UriSwab-Urine Collection, Transport and Preservation System (Mar 23, 2018)
- K142094: Copan Fecalswab Collection, Transport and Preservation System (Apr 10, 2015)
- K972449: Copan Venturi Transystem Amies Medium with Charcoal (Aug 20, 1997)
- K972448: Copan Venturi Transystem Amies Medium Without Charcoal (Aug 20, 1997)

Source page: https://510kreport.com/company/copan-italia