# K910320: Serim Peracetic Acid Reagent Strips

- Pathway: 510(k) (Traditional)
- Applicant: Serim Research Corp.
- Decided: May 1, 1991 after 97 days
- Product code: JOJ (Indicator, Physical/Chemical Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 2 cite it directly.
0 of 12 devices 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.

## Most influential descendants
- K972035: Sporox Test Strips (1997), 9 descendants of its own
- K081600: Steris Resert XL Test Strip (2008), 8 descendants of its own
- K102217: System 1E Chemical Indicator (2010), 5 descendants of its own
- K173428: VERIFY Chemical Indicator for S40 Sterilant (2018), 3 descendants of its own
- K240032: Celerity Chemical Indicator for enspire 3000 CLCSPS (2024), 1 descendant of its own

Source page: https://510kreport.com/device/K910320
Methodology: https://510kreport.com/methodology