# K111377: Sterrad (R) 100NX Sterilizer Duo Cycle

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Sep 13, 2012 after 486 days
- Product code: MLR (Sterilizer, Chemical)
- Device class: 2
- Regulation: 21 CFR 880.6860
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K981625 (1999). 5 ancestors in all.
17 later devices descend from it; 4 cite it directly.
0 of 23 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.
- K991999: Sterrad 100S Sterilizer, Advanced Sterilization Products (2000) Summary page 1.
- K023290: Sterrad 50 & Sterrad 100S Sterilizers, Advanced Sterilization Products (2003) Summary page 1.

## Most influential descendants
- K142454: STERRAD NX Sterilizer, STERRAD 100NX Sterilizer (2015), 9 descendants of its own
- K141163: Sterizone Sterilizer (2014), 5 descendants of its own
- K160903: STERRAD 100NX Sterilizer with ALLClearTM Technology (2016), 4 descendants of its own
- K153392: STERIZONE  VP4  Sterilizer (2016), 4 descendants of its own
- K212174: STERRAD 100NX Sterilizer with ALLClear Technology (2021), 3 descendants of its own

## Recalls of this device
- Nov 4, 2014 · Class II · Z-0846-2015: Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen 

## 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 safely sterilize medical instruments and materials without leaving toxic residue. 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 10.1 lbs placed on the bottom shelf. The STERRAD® 100NX® DUO Cycle is an additional optional cycle designed for sterilization of medical devices including most flexible endoscopes, with the following materials and dimensions: > Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and a length of 875 mm or shorter > Accessory devices that are normally connected to a flexible endoscope during use > Flexible endoscopes without lumens Note: The validation studies for DUO Cycle were performed using a validation load consisting of two flexible endoscopes with their accessory devices weighing a total of 13.2 lbs.

Source page: https://510kreport.com/device/K111377
Methodology: https://510kreport.com/methodology