# K234082: STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Jul 5, 2024 after 196 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: 6 generations back to K042116 (2005). 12 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212174: STERRAD 100NX Sterilizer with ALLClear Technology, Advanced Sterilization Products, Inc. (2021) Summary page 6.
- K013003: Aptimax Instrument Tray, Instrument Mat and Instrument Holder, Advanced Sterilization Products (2002) Summary page 6.

## Most influential descendants
- K250802: STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) (2025), 1 descendant of its own
- K252843: STERRAD 100NX Sterilization System with ALLClear Technology (10104) (2026), 0 descendants of its own

## Indications for use
The STERRAD 100NX Sterilizer with ALLClear Technology 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. A maximum of ten single channel stainless steel lumens, five per tray per sterilization cycle. 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 1065 mm or shorter. A maximum of two flexible endoscopes, one per tray per sterilization cycle. No additional load. Note: With the exception of the 1 x 1065 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 1065 mm flexible endoscopes were validated without any 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. The STERRAD 100NX Sterilizer ULTRA GI Cycle is designed for sterilization of the following: • Hydrogen peroxide compatible flexible multi-channel duodenoscopes, with no more than 4 channels, with lumen dimensions having an inside diameter (ID) of ≥1mm x ≤1500mm in length, or ≥2mm ID x ≤1630mm in length. • One flexible duodenoscope per tray, and no more than two flexible duodenoscope per cycle Note1: The STERRAD 100NX Sterilizer ULTRA GI Cycle was validated using a load weight of 15.4 lbs (2 x 7.7 lbs), one endoscope per shelf. Note 2: Only duodenoscopes that have been cleared as compatible with vaporized hydrogen peroxide are acceptable. Check STERRAD User Guide "STERRAD Sterilizer Cycle Selection table" for ULTRA GI Cycle compatible duodenoscopes. The APTIMAX™ Tray for ULTRA GI™ Cycle is designed to encase surgical instruments for sterilization in STERRAD™ 100NX Sterilization System with ALLCLEAR™ Technology: • ULTRA GI™ Cycle

Source page: https://510kreport.com/device/K234082
Methodology: https://510kreport.com/methodology