# K970536: Medisystems Tranducer Protector

- Pathway: 510(k) (Traditional)
- Applicant: Medisystems Corp.
- Decided: May 12, 1997 after 89 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 K895856 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
Medisystems Transducer Protectors are single use, disposable prescription devices intended for use as protective devices for pressure monitors and to help protect the sterility of the fluid pathway.

Source page: https://510kreport.com/device/K970536
Methodology: https://510kreport.com/methodology