# Terumo Europe N.V.

- Location (FDA's records): Leuven, BE
- FDA decisions: 28 (1999–2025): 28 510(k) clearances
- Product codes: FMI (15), FPA (7), FMF (4), QYM (1), JKA (1)
- 510(k) review time since 2016: median 181 days, against 141 for FDA's reviews in the same codes and years (2 of 6 faster)
- Predicates its devices cite: 50 (32 its own); citations of its devices by later devices: 42 (32 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
- Terumo Medical Corp.: 8 (https://510kreport.com/company/terumo-medical)
- Terumo Corp.: 3 (https://510kreport.com/company/terumo)
- Terumo (Philippines) Corporation: 2 (https://510kreport.com/company/terumo-philippines)
- Terumo America, Inc.: 1 (https://510kreport.com/company/terumo-america)
- Tri-Ject Intl. Corp.: 1 (https://510kreport.com/company/tri-ject-intl)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 1 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)
- Novo Nordisk, Inc.: 1 (https://510kreport.com/company/novo-nordisk)
- Becton, Dickinson & CO: 1 (https://510kreport.com/company/becton-dickinson)

## Firms that cite its devices most
- Delta Med Spa: 2 (https://510kreport.com/company/delta-med)
- Rongshan LI: 1 (https://510kreport.com/company/rongshan-li)
- Yangzhou Medline Industry, Co., Ltd.: 1 (https://510kreport.com/company/yangzhou-medline-industry)
- Terumo (Philippines) Corporation: 1 (https://510kreport.com/company/terumo-philippines)
- Pikdare Spa: 1 (https://510kreport.com/company/pikdare)
- Altaviz, LLC: 1 (https://510kreport.com/company/altaviz)
- Tsk Laboratory International Japan KK: 1 (https://510kreport.com/company/tsk-laboratory-international-japan)
- Imprint Pharmaceuticals Limited: 1 (https://510kreport.com/company/imprint-pharmaceuticals)

## Its most-cited devices
- K984576: K-Pack II (Hypodermic Needle) 23G X 1, Model KN-2325RB, K-Pack II Needle (Hypodermic Needle) 25G X 1, Model KN-2525RB, K (1999), cited by 8
- K001572: Neolus Needle (2000), cited by 4
- K052887: Surflo Winged Infusion Set with Needle Protection (Surshield), Model SV-S23BL35VS (2005), cited by 4
- K110850: K-Pack II Needle- 27G & 30G Thin Wall (2011), cited by 3
- K082820: K-Pack II Needle - 29G Thin Wall (2008), cited by 3
- K070547: Surflo Winged Infusion Set with Filter and Needle Protection (Surshield) (2007), cited by 3

## Recent decisions
- K251447: K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) (Jul 8, 2025)
- K243309: 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) (May 29, 2025)
- K243581: K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) (Apr 4, 2025)
- K230951: Terumo Injection Filter Needle (NF-3013RBKE05M) (Oct 18, 2023)
- K212095: SurGuard3 Safety Hypodermic Needle (Aug 22, 2022)
- K192057: K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin Wall, K-Pack II Needle - 30G x 1/2” Extra Thin Wall, K-Pack II Needle - 30G x 1/2” Ultra Thin Wall (Oct 11, 2019)
- K161606: Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH (Feb 10, 2017)
- K151398: K-Pack II Needle - 29G x 5/16 Thin Wall (Jun 25, 2015)

Source page: https://510kreport.com/company/terumo-europe