# K092622: Sterrad 100NX Sterilizer Express Cycle

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Mar 4, 2011 after 555 days
- Product code: MLR (Sterilizer, Chemical)
- Device class: 2
- Regulation: 21 CFR 880.6860
- 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 K042116 (2005). 3 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071385: Sterrad 100NX Sterilizer, Advanced Sterilization Products (2007) Summary page 1.
- K030429: Sterrad 200 Sterilizer, Advanced Sterilization Products (2003) Summary page 1.

## Most influential descendants
- K142454: STERRAD NX Sterilizer, STERRAD 100NX Sterilizer (2015), 9 descendants of its own
- K160903: STERRAD 100NX Sterilizer with ALLClearTM Technology (2016), 4 descendants of its own
- K212174: STERRAD 100NX Sterilizer with ALLClear Technology (2021), 3 descendants of its own
- K234082: STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077) (2024), 2 descendants of its own
- K250802: STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) (2025), 1 descendant of its own

## Indications for use
The STERRAD® 100NX™ Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. The STERRAD sterilization process is a multiphase sterilization process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to affect sterilization. The STERRAD® 100NX™ Sterilizer can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. Medical devices with the following materials and dimensions can be processed in the STERRAD® 100NX™ Sterilizer Standard cycle: > Single channel stainless steel lumens with an inside diameter of 0.7 mm or larger and a length of 500 mm or shorter* Medical devices, including most flexible endoscopes, with the following materials and dimensions can be processed in the STERRAD® 100NX™ Sterilizer Flex Scope cycle: > Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and length of 850 mm or shorter** Note: With the exception of the 1 x 850 mm flexible endoscopes, the validation studies were performed using a validation load consisting of two instrument trays each weighing 10.7 lbs. The 1 x 850 mm flexible endoscopes were validated without any additional load. *A maximum of ten single channel stainless steel lumens, five per tray per sterilization cycle. **A maximum of two flexible endoscopes, one per tray per sterilization cycle. No additional load. The STERRAD® 100NX™ EXPRESS Cycle is an additional optional cycle designed for surface sterilization of both metal and nonmetal medical devices at low temperatures. > It can sterilize instrument surfaces and instruments having diffusion-restricted spaces, such as the hinged portion of forceps and scissors > It can sterilize rigid and semi-rigid endoscopes without lumens Note: The validation studies for EXPRESS Cycle were performed using a validation load consisting of a single instrument tray weighing 10.7 lbs placed on the bottom shelf.

Source page: https://510kreport.com/device/K092622
Methodology: https://510kreport.com/methodology