# Plastiflex Group NV

- Location (FDA's records): Claremont, NH
- FDA decisions: 2 (2010–2016): 2 510(k) clearances
- Product codes: BZE (2)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 4 (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 Asd, Inc.: 1 (https://510kreport.com/company/smiths-medical-asd)
- Fisher & Paykel Healthcare, Ltd.: 1 (https://510kreport.com/company/fisher-paykel-healthcare)
- Intersurgical, Inc.: 1 (https://510kreport.com/company/intersurgical)

## Firms that cite its devices most
- Medline Industries, Inc.: 2 (https://510kreport.com/company/medline-industries)
- Respironics, Inc.: 1 (https://510kreport.com/company/respironics)
- Grundler GmbH: 1 (https://510kreport.com/company/grundler)

## Its most-cited devices
- K100104: Hybernite Rainout Control System (2010), cited by 2
- K151461: Hybernite RT (2016), cited by 2

## Recent decisions
- K151461: Hybernite RT (Mar 24, 2016)
- K100104: Hybernite Rainout Control System (Apr 14, 2010)

Source page: https://510kreport.com/company/plastiflex-group