# K071385: Sterrad 100NX Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Nov 29, 2007 after 195 days
- Product code: MLR (Sterilizer, Chemical)
- Device class: 2
- Regulation: 21 CFR 880.6860
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K042116 (2005). 1 ancestor in all.
19 later devices descend from it; 4 cite it directly.
0 of 21 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 1.

## Most influential descendants
- K111377: Sterrad (R) 100NX Sterilizer Duo Cycle (2012), 17 descendants of its own
- K092622: Sterrad 100NX Sterilizer Express Cycle (2011), 10 descendants of its own
- K142454: STERRAD NX Sterilizer, STERRAD 100NX Sterilizer (2015), 9 descendants of its own
- K141163: Sterizone Sterilizer (2014), 5 descendants of its own
- K160903: STERRAD 100NX Sterilizer with ALLClearTM Technology (2016), 4 descendants of its own

## Recalls of this device
- Nov 11, 2013 · Class II · Z-0402-2014: Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the s
- Sep 18, 2013 · Class II · Z-0044-2014: Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak indicator on the cassettes is effective for 
- Jul 25, 2013 · Class II · Z-2174-2013: The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (ASP) does not have adequate data to support the effectiveness of the packaging's leak indicator for the
- Mar 22, 2013 · Class II · Z-1026-2013: The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding enviro
- Feb 25, 2008 · Not classified · Z-1632-2008: Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result in the release of a mist, "haze," or "smoke."

## Indications for use
The STERRAD® 100NXTM 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® 100NX TM 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 100NXTM 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® 100NXTM 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.

Source page: https://510kreport.com/device/K071385
Methodology: https://510kreport.com/methodology