# Medisystems Corp.

- Location (FDA's records): Mchenry, IL
- FDA decisions: 22 (1981–2007): 22 510(k) clearances
- Product codes: FIE (6), KOC (5), FIB (3), FJK (2), FMI (2), FPA (2), KDJ (1), FJI (1)
- Predicates its devices cite: 10 (5 its own); citations of its devices by later devices: 19 (5 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Tnt Moborg Intl., Ltd.: 2 (https://510kreport.com/company/tnt-moborg-intl)
- Jms Co., Ltd.: 1 (https://510kreport.com/company/jms)
- Tri-Med, Inc.: 1 (https://510kreport.com/company/tri-med)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 1 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)

## Firms that cite its devices most
- Nxstage Medical, Inc.: 3 (https://510kreport.com/company/nxstage-medical)
- Nipro Medical Corporation: 3 (https://510kreport.com/company/nipro-medical)
- Kawasumi Laboratories Co., Ltd.: 2 (https://510kreport.com/company/kawasumi-laboratories)
- Jms North America Corp.: 2 (https://510kreport.com/company/jms-north-america)
- Vital Access: 1 (https://510kreport.com/company/vital-access)
- Vasc-Alert, LLC: 1 (https://510kreport.com/company/vasc-alert)
- Fresenius Medical Care: 1 (https://510kreport.com/company/fresenius-medical-care)
- Itl Corporation Pty, Ltd.: 1 (https://510kreport.com/company/itl)

## Its most-cited devices
- K932074: Medisystems Apheresis Needle with Guard (1994), cited by 4
- K990803: Medisystems Buttonhole Needle Sets (2000), cited by 4
- K953823: Arterial Venous Blood Tubing Set (1996), cited by 3
- K994306: Reverso (2000), cited by 2
- K895856: Medisystems Transducer Protector (1989), cited by 2
- K823068: Medisystems Fistula Needles (1983), cited by 1

## Recent decisions
- K062953: Medisystems Arterial-Venous Fistula Needle Set with Securement Device (Feb 12, 2007)
- K010279: Medisystems Luer Access Injection Site (May 29, 2001)
- K002372: Access Alert Gauge (Oct 25, 2000)
- K994306: Reverso (Mar 20, 2000)
- K990803: Medisystems Buttonhole Needle Sets (Jan 6, 2000)
- K983076: Medisystems Transducer Protector (Nov 25, 1998)
- K971860: Medisystems Dialysis Priming Sets (Aug 18, 1997)
- K963668: Medisystems Peritoneal Dialysis Sets (Aug 15, 1997)

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