# Bio-Plexus, Inc.

- Location (FDA's records): Tolland, CT
- FDA decisions: 6 (1990–2001): 6 510(k) clearances
- Product codes: FMI (6)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 8 (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 that cite its devices most
- Luther Medical Products, Inc.: 1 (https://510kreport.com/company/luther-medical-products)
- MDC Research, Ltd.: 1 (https://510kreport.com/company/mdc-research)
- Fresenius Medical Care: 1 (https://510kreport.com/company/fresenius-medical-care)
- Teleflex Medical: 1 (https://510kreport.com/company/teleflex-medical)
- Medisys Technologies, Inc.: 1 (https://510kreport.com/company/medisys-technologies)
- Tfx Medical, Inc.: 1 (https://510kreport.com/company/tfx-medical)
- Becton Dickinson Vacutainer Systems: 1 (https://510kreport.com/company/becton-dickinson-vacutainer-systems)

## Its most-cited devices
- K895024: Punctur-Guard (TM) Blood Collection Needle (1990), cited by 5
- K963748: Bio-Plexus Drop-IT Needle Holder (1997), cited by 2
- K003827: Punctur-Guard Winged Set for Blood Collection (2001), cited by 1

## Recent decisions
- K003827: Punctur-Guard Winged Set for Blood Collection (Jan 8, 2001)
- K992091: Punctur-Guard Revolution Holder, Model 4750 (Sep 9, 1999)
- K963748: Bio-Plexus Drop-IT Needle Holder (Jun 6, 1997)
- K960933: Bio-Plexus Needle Disposal Container (Aug 28, 1996)
- K961251: Punctur-Guard Winged Set (Jun 27, 1996)
- K895024: Punctur-Guard (TM) Blood Collection Needle (Sep 21, 1990)

Source page: https://510kreport.com/company/bio-plexus