# K240164: NovaLine SP-C35 Transducer Protector (956007)

- Pathway: 510(k) (Traditional)
- Applicant: Bain Medical Equipment (Guangzhou) Co., Ltd.
- Decided: Jun 28, 2024 after 158 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: 3 generations back to K820459 (1982). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072988: Nipro Transducer Protector TP-Sure, Model Tpsure+1, Nipro Medical Corporation (2008) Summary page 7.

## Indications for use
The NovaLine SP-C35 Transducer Protector is a single-use, disposable, prescription device intended for use as a protective device for pressure monitors and to help prevent contamination of the fluid pathway in hemodialysis delivery systems.

Source page: https://510kreport.com/device/K240164
Methodology: https://510kreport.com/methodology