# K970230: Sporox

- Pathway: 510(k) (Traditional)
- Applicant: Reckitt Benckiser, Inc.
- Decided: Oct 29, 1997 after 281 days
- Product code: MED (Sterilant, Medical Devices)
- Device class: 2
- Regulation: 21 CFR 880.6885
- 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 K924334 (1994). 1 ancestor in all.
7 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924334: Cidex Formula 7* Long-Life Activated Dialdehyde, Johnson & Johnson Medical, Inc. (1994) Summary page 1.

## Most influential descendants
- K103059: Trophon (2011), 3 descendants of its own
- K173865: trophon2 (2018), 2 descendants of its own
- K080420: Resert  XL HLD High Level Disinfectant (2008), 1 descendant of its own
- K250434: trophon2 (2025), 0 descendants of its own
- K241536: trophon Wireless Ultrasound Probe Holder (2024), 0 descendants of its own

## Indications for use
Sporox® Sterilizing & Disinfecting Solution is a ready-to-use liquid chemical germicide. The product is a 7.5% nominal hydrogen peroxide solution buffered with phosphoric acid. The minimum effective concentration (MEC) is 6%. Sporox® Sterilizing and Disinfecting Solution is intended for use in the high level disinfection of heat sensitive medical equipment using the prescribed contact conditions. Devices must be soaked for 30 minutes at 20°C to high level disinfect. Sporox® may be reused for up to 21 days in conjunction with the use of an appropriate chemical indicator strip.

Source page: https://510kreport.com/device/K970230
Methodology: https://510kreport.com/methodology