# K253863: GUARDIAN™ Quick Dip Residual Chlorine (5212)

- Pathway: 510(k) (Traditional)
- Applicant: Serim Research
- Decided: Mar 17, 2026 after 104 days
- Product code: FKJ (Filter, Blood, 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 K901734 (1990). 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)
- K901734: Serim Residual Chlorine Test Kit, Serim Research Corp. (1990) Summary page 5.

## Indications for use
GUARDIAN™ Quick Dip Residual Chlorine (5212) Test Strips provide a convenient means for indicating the concentration of chlorine bleach (sodium hypochlorite) remaining in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment.

Source page: https://510kreport.com/device/K253863
Methodology: https://510kreport.com/methodology