# Novo Nordisk, Inc.

- Location (FDA's records): Plainsboro, NJ
- FDA decisions: 14 (2005–2023): 14 510(k) clearances
- Product codes: FMI (10), FMF (4)
- 510(k) review time since 2016: median 110 days, against 145 for FDA's reviews in the same codes and years (4 of 6 faster)
- Predicates its devices cite: 27 (19 its own); citations of its devices by later devices: 27 (19 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Becton, Dickinson & CO: 4 (https://510kreport.com/company/becton-dickinson)
- Novo Norodisk Pharmaceuticals, Inc.: 2 (https://510kreport.com/company/novo-norodisk-pharmaceuticals)
- Novo Nordisk A/S: 1 (https://510kreport.com/company/novo-nordisk-a-s)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 1 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)

## Firms that cite its devices most
- Wuxi Nest Biotechnology Co., Ltd.: 2 (https://510kreport.com/company/wuxi-nest-biotechnology)
- Terumo Europe N.V.: 1 (https://510kreport.com/company/terumo-europe)
- Scandinavian Health Limited: 1 (https://510kreport.com/company/scandinavian-health)
- Artsana S.P.A: 1 (https://510kreport.com/company/artsana)
- Shina Corp.: 1 (https://510kreport.com/company/shina)
- Facet Technologies, LLC: 1 (https://510kreport.com/company/facet-technologies)
- Companion Medical, Inc.: 1 (https://510kreport.com/company/companion-medical)

## Its most-cited devices
- K050106: Novofine Autocover 30G X 8MM (2005), cited by 5
- K090111: Flexpen Needle (2010), cited by 5
- K062500: Flexpen Needle (2006), cited by 3
- K123766: Novopen Echo, a Dial a Dose Insulin Delivery Pen (2013), cited by 3
- K053470: Novofine 32G Tip (2005), cited by 2
- K182387: NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) (2018), cited by 2

## Recent decisions
- K231255: NovoFine® Plus (Aug 25, 2023)
- K210258: NovoFine (Jun 23, 2021)
- K202005: NovoFine Plus 32G Tip x 4 mm (Dec 19, 2020)
- K182387: NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) (Dec 17, 2018)
- K173479: NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) (Jan 17, 2018)
- K162602: NovoPen Echo (Oct 18, 2016)
- K150874: NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) (Jul 31, 2015)
- K133738: Novofine Plus 32G 4 MM (May 21, 2014)

Source page: https://510kreport.com/company/novo-nordisk