# K142454: STERRAD NX Sterilizer, STERRAD 100NX Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Apr 3, 2015 after 213 days
- Product code: MLR (Sterilizer, Chemical)
- Device class: 2
- Regulation: 21 CFR 880.6860
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K042116 (2005). 8 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042116: Sterrad NX Sterilizer, Advanced Sterilization Products (2005) Summary page 6.
- K071385: Sterrad 100NX Sterilizer, Advanced Sterilization Products (2007) Summary page 6.
- K092622: Sterrad 100NX Sterilizer Express Cycle, Advanced Sterilization Products (2011) Summary page 6.
- K111377: Sterrad (R) 100NX Sterilizer Duo Cycle, Advanced Sterilization Products (2012) Summary page 6.

## Most influential descendants
- 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
- K160818: STERRAD® NX Sterilizer with ALLClear™ Technology (2016), 1 descendant of its own

## Recalls of this device
- Jan 9, 2017 · Class II · Z-1197-2017: Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during system reboot for a
- Jul 17, 2015 · Class II · Z-2375-2015: Advanced Sterilization PRoducts (ASP) is recalling the Wall Chart for STERRAD 100NX System because it incorrectly states "APTIMAX Instrument Trays can be enclosed in either polypropylene wrap or in Ty

## Indications for use
The STERRAD® NX® 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® NX® 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® NX® Sterilizer Standard cycle: Single channel stainless steel lumens with * An inside diameter of 1 mm or larger and a length of 150 mm or shorter† * An inside diameter of 2 mm or larger and a length of 400 mm or shorter† Medical devices, including most flexible endoscopes, with the following materials and dimensions can be processed in the STERRAD® NX® Sterilizer Advanced cycle: Single channel stainless steel lumens with * An inside diameter of 1 mm or larger and a length of 500 mm or shorter† Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscope with * An inside diameter of 1 mm or larger and length of 850 mm or shorter* † The validation testing for this lumen size was conducted using a maximum of 10 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. *Only one flexible endoscope can be processed per sterilization cycle with or without a silicone mat. No additional load. Note: With the exception of the 1 x 850 mm flexible endoscopes, the validation studies were performed using a validation load consisting of one instrument tray weighing 10.7 lbs. The 1 x 850 mm flexible endoscope was validated without any additional load. 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 10.7 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/K142454
Methodology: https://510kreport.com/methodology