# K151725: STERRAD NX Sterilizer, STERRAD 100NX Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Jan 13, 2016 after 201 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: 4 generations back to K042116 (2005). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142454: STERRAD NX Sterilizer, STERRAD 100NX Sterilizer, Advanced Sterilization Products (2015) Summary page 6.

## Most influential descendants
- K162007: STERRAD NX Sterilizer (2017), 0 descendants 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

## 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/K151725
Methodology: https://510kreport.com/methodology