# K080712: Serim Hisense Ultra 0.1, Part Number 5167

- Pathway: 510(k) (Traditional)
- Applicant: Serim Research Corp.
- Decided: May 6, 2008 after 54 days
- Product code: MSY (Strip, Test, Reagent, Residuals For Dialysate, Disinfectant)
- Device class: 2
- Regulation: 21 CFR 876.5665
- 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 K001194 (2000). 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)
- K001194: Sterichek Total Chlorine Reagent Strips, Environmental Test Systems, Inc. (2000)

## Indications for use
SERIM® HiSENSE ULTRA 0.1TM Test Strips provide a convenient means for indicating the concentration of residual chlorine (chlorine bleach) detected in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment. HiSENSE ULTRA 0.1 also provides a quick and convenient means for indicating low levels of total chlorine (chloramines/free chlorine) in water used to prepare dialysate.

Source page: https://510kreport.com/device/K080712
Methodology: https://510kreport.com/methodology