# K983076: Medisystems Transducer Protector

- Pathway: 510(k) (Traditional)
- Applicant: Medisystems Corp.
- Decided: Nov 25, 1998 after 84 days
- Product code: FIB (Protector, Transducer, Dialysis)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K820459 (1982). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895856: Medisystems Transducer Protector, Medisystems Corp. (1989) Summary page 1.
- K820459: Viragard/Virashield, Tri-Med, Inc. (1982) Summary page 1.

## Most influential descendants
- K072988: Nipro Transducer Protector TP-Sure, Model Tpsure+1 (2008), 1 descendant of its own
- K240164: NovaLine SP-C35 Transducer Protector (956007) (2024), 0 descendants of its own

## Indications for use
Medisystems Transducer Protectors are indicated for use as protective devices for pressure monitors on hemodialysis machines as well as to help protect the sterility of the blood tubing fluid pathway. The filter helps prevent cross-contamination by viruses, bacteria, and other particulate matter while preventing the flow of fluids to the hemodialysis machine’s pressure transducer.

Source page: https://510kreport.com/device/K983076
Methodology: https://510kreport.com/methodology