# Haemotronic, Inc.

- Location (FDA's records): Fairfield, NJ
- FDA decisions: 6 (1992–2021): 6 510(k) clearances
- Names in FDA's records: Haemotronic, Inc. (4); Haemotronic S.P.A. (2)
- Product codes: KPE (2), FPA (1), KOC (1), BRZ (1), FJK (1)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 2 (1 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
- Acta Medical, LLC: 1 (https://510kreport.com/company/acta-medical)

## Firms that cite its devices most
- Fresenius Kabi AG: 1 (https://510kreport.com/company/fresenius-kabi)

## Its most-cited devices
- K210749: Empty EVA Bag (2021), cited by 1
- K193528: Empty EVA Bag (2020), cited by 1

## Recent decisions
- K210749: Empty EVA Bag (Aug 19, 2021)
- K193528: Empty EVA Bag (Jul 22, 2020)
- K921597: Cavh/CVVH/Cavhd Set Model #HT-HF/505 (Feb 24, 1995)
- K921594: Haemotrol Model #HT-SB/6 Burette Set (Dec 24, 1992)
- K921595: Y-Type Blood Administration Set Model #HT-TR2 (Dec 24, 1992)
- K913361: Drain/Priming/Recirculation Bag (Mar 30, 1992)

Source page: https://510kreport.com/company/haemotronic