# K220404: STERRAD NX with ALLClear Technology

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products, Inc.
- Decided: May 16, 2022 after 91 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)
- K160818: STERRAD® NX Sterilizer with ALLClear™ Technology, Advanced Sterilization Products (2016) Summary page 5.

## 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.† • Single-channel stainless steel lumens with an inside diameter of 2 mm or larger and a length of 400 mm or shorter.† †The validation testing for this lumen size was conducted using a maximum of 10 lumens per load. Your loads should not exceed the maximum number of lumens validated by this testing. 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 PE/PTFE flexible endoscopes with an inside diameter of 1 mm or larger and a length of 1065 mm or shorter.* Note: With the exception of the flexible endoscopes, the validation studies were performed using a validation load consisting of devices in one instrument tray weighing 10.7 lbs (4.9 kg). The flexible endoscopes were validated without any additional load.** †The validation testing for this lumen size was conducted using a maximum of 10 lumens per load. Your loads should not exceed the maximum number of lumens validated by this testing. * Only one flexible endoscope up to 1065 mm long with or without APTIMAX Instrument Tray Holders can be used per cycle, or only one flexible endoscope up to 850 mm long per cycle with or without a STERRAD Instrument Tray Mat. No additional load. Check the medical device manufacturer’s instructions for use prior to processing any scope in the STERRAD NX Sterilizer; and check if Instrument tray mats or only tray holders are validated for use with flexible endoscopes longer than 850 mm. **The validation testing for flexible endoscopes up to 850 mm long was conducted with one endoscope per cycle using a STERRAD Instrument Tray Mat to help protect the endoscope no additional load. The validation testing for flexible endoscopes longer that 850 mm was conducted with one endoscope per cycle using APTIMAX Instrument Tray Holders to assist with device placement and help protect the endoscope: no additional load.

Source page: https://510kreport.com/device/K220404
Methodology: https://510kreport.com/methodology