# K250802: STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products, Inc.
- Decided: Apr 14, 2025 after 31 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: 7 generations back to K042116 (2005). 13 ancestors in all.
1 later device descends 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)
- K234082: STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077), Advanced Sterilization Products (2024) Summary page 6.

## Most influential descendants
- 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 Ibs. The 1 x 1065 mm flexible endoscopes were validated without any additional load. The STERRAD 100NX EXPRESS Cycle is 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 Ibs placed on the bottom shelf. The STERRAD 100NX DUO Cycle is 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 1: 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 Ibs. * One Dual channel flexible endoscope with two polyethylene and Teflon (polytetrafluoroethylene) lumens that each have an inside diameter of 1 mm or larger and a length of 885 mm or shorter. Note 2: The validation studies for DUO Cycle was performed using a validation load consisting of 1 dual channel endoscope with >1 mm diameter x <885 mm long and >2.2 mm diameter x <835 mm long PTFE/PE lumens, and 1 dual channel endescope with >1 mm diameter x <670 mm long and >2.2 mm diameter x <845 mm long PTFE/PE lumens The STERRAD 100NX Sterilizer ULTRA GI Cycle is designed for sterilization of the following: » Medical devices, including multi-channel endoscopes (including duodenoscopes), with no more than 4 channels, with lumen dimensions of >1mm x <1500mm in length, and >2mm x <1630mm in length. * One flexible endoscope per tray, and no more than two flexible endoscopes per cycle Notel: The STERRAD 100NX Sterilizer ULTRA GI Cycle was validated using a load weight of 15.4 lbs (2 x 7.7 Ibs), 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 compatible duodenoscopes.

Source page: https://510kreport.com/device/K250802
Methodology: https://510kreport.com/methodology