# K013280: Sterilox Liquid Chemical Sterilant System

- Pathway: 510(k) (Traditional)
- Applicant: Sterilox Technologies, Inc.
- Decided: Sep 18, 2002 after 351 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: 2 generations back to K875280 (1988). 6 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923744: Cidex Plus 28 Day Solution, Johnson & Johnson Medical, Inc. (1994) Summary page 2.
- K924334: Cidex Formula 7* Long-Life Activated Dialdehyde, Johnson & Johnson Medical, Inc. (1994) Summary page 2.
- K924434: Cidex Activated Dialdehyde Solution, Johnson & Johnson Medical, Inc. (1994) Summary page 2.
- K972708: Endo-Spor Plus / Hyprocide, Cottrell, Ltd. (1999) Summary page 2.
- K875280: Steris System 1 Processor and 20 Sterilant, Steris C/O Medical Device Consultants, Inc. (1988) Summary page 2.

## Most influential descendants
- K090036: System 1.5 Sterile Processing System (2010), 4 descendants of its own
- K101409: System IE Liquid Chemical Cterilant Processing System (2010), 3 descendants of its own
- K102462: System 1E Liquid Chemical Sterilant Processing System (2010), 2 descendants of its own
- K113520: System 1E Liquid Chemical Sterilant Processing System (2012), 1 descendant of its own
- K131078: System 1E Liquid Chemical Sterilant Processing System (2013), 0 descendants of its own

## Indications for use
Sterilox is a high level disinfectant system intended for processing heat-sensitive medical devices when used according to the User Manual with an immersion time of ten (10) minutes at 25°C. Sterilox is a single use product generated on site for use at its MRC of 650-675 ppm (AFC). Sterilox is intended for use with manual or automatic endoscope reprocessing protocols. This device is intended for use by qualified healthcare personnel trained in its use.

Source page: https://510kreport.com/device/K013280
Methodology: https://510kreport.com/methodology