# K012115: Serim Blood Leak Test Strip-2

- Pathway: 510(k) (Traditional)
- Applicant: Serim Research Corp.
- Decided: Nov 30, 2001 after 147 days
- Product code: FJD (Detector, Leak, Blood)
- 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: 2 generations back to K896454 (1990). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896454: Chemstrip (R) 10 with SG Urine Test Strips, Boehringer Mannheim Corp. (1990) Summary page 1.
- K990206: Serim Blood Leak Test Strip, Serim Research Corp. (1999) Summary page 2.

## Most influential descendants
- K042322: Sterichek Blood Leak Reagent Strips (2004), 0 descendants of its own

## Indications for use
Serim Blood Leak Test Strips —2 provide a rapid and convenient means for testing dialysate for blood if a dialyzer membrane leak is suspected during the conventional hemodialysis procedure or continuous renal replacement therapy procedures such as continuous arteriovenous hemodialysis or continuous venovenous hemodialysis.

Source page: https://510kreport.com/device/K012115
Methodology: https://510kreport.com/methodology