# K003615: Sterichek Sensitive-Feed Water and Rinse Water Reagent Strips

- Pathway: 510(k) (Special)
- Applicant: Environmental Test Systems, Inc.
- Decided: Feb 1, 2001 after 71 days
- Product code: FKP (System, Dialysate Delivery, Single Patient)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- May 23, 2008 · Not classified · Z-2354-2008: Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results
- May 23, 2008 · Not classified · Z-2355-2008: Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results
- May 23, 2008 · Not classified · Z-2352-2008: Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results
- May 23, 2008 · Not classified · Z-2353-2008: Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results

Source page: https://510kreport.com/device/K003615
Methodology: https://510kreport.com/methodology