# K162007: STERRAD NX Sterilizer

- Pathway: 510(k) (Special)
- Applicant: Advanced Sterilization Products
- Decided: Feb 16, 2017 after 211 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: 5 generations back to K042116 (2005). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 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 5.
- K142454: STERRAD NX Sterilizer, STERRAD 100NX Sterilizer, Advanced Sterilization Products (2015) Summary page 9.
- K151725: STERRAD NX Sterilizer, STERRAD 100NX Sterilizer, Advanced Sterilization Products (2016) Summary page 9.

## 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* Note: With the exception of the 1 x 850 mm flexible endoscopes, 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 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.

Source page: https://510kreport.com/device/K162007
Methodology: https://510kreport.com/methodology