# Unomedical A/S

- Location (FDA's records): Roskilde, DK
- FDA decisions: 13 (2003–2021): 13 510(k) clearances
- Product codes: FPA (12), FOZ (1)
- 510(k) review time since 2016: median 142 days, against 186 for FDA's reviews in the same codes and years (4 of 5 faster)
- Predicates its devices cite: 29 (11 its own); citations of its devices by later devices: 14 (11 its own)
- Recalls linked to its devices: 14 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Maersk Medical A/S: 9 (https://510kreport.com/company/maersk-medical-a-s)
- P/L Biomedical: 5 (https://510kreport.com/company/p-l-biomedical)
- Minimed, Inc.: 1 (https://510kreport.com/company/minimed)
- Medtronic Minimed: 1 (https://510kreport.com/company/medtronic-minimed)
- Unomedical A/S Infusion Devices: 1 (https://510kreport.com/company/unomedical-a-s-infusion-devices)
- Patton Medical Devices: 1 (https://510kreport.com/company/patton-medical-devices)

## Firms that cite its devices most
- Capillary Biomedical, LLC: 1 (https://510kreport.com/company/capillary-biomedical)
- Unomedical A/S Infusion Devices: 1 (https://510kreport.com/company/unomedical-a-s-infusion-devices)
- Deka Research and Development: 1 (https://510kreport.com/company/deka-research-and-development)

## Its most-cited devices
- K032854: Unomedical Monica Infusion Set (2003), cited by 8
- K173879: MiniMed Mio Advance infusion set (2018), cited by 2
- K061374: Intuition Infusion Sets (2006), cited by 1
- K051264: Comfort and Inset Subcutaneous Infusion Sets for Use with Abbott Infusion Pumps (2005), cited by 1
- K041545: Contact Detach (2004), cited by 1
- K160648: MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® (2016), cited by 1

## Recent decisions
- K210544: Medtronic Extended infusion set (Jul 16, 2021)
- K192647: neria guard Infusion Set (Dec 13, 2019)
- K173879: MiniMed Mio Advance infusion set (Mar 5, 2018)
- K162812: Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set (Nov 1, 2017)
- K160648: MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® (Aug 10, 2016)
- K132142: Neria Soft 90 Infusion Set (Oct 8, 2013)
- K120337: I-Port Advance Injection Port (Feb 16, 2012)
- K070430: Paradigm Quick-Set II and Quick-Set II Subcutaneous Infusion Sets (Apr 4, 2007)

Source page: https://510kreport.com/company/unomedical-a-s