# K042116: Sterrad NX Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Apr 22, 2005 after 260 days
- Product code: MLR (Sterilizer, Chemical)
- Device class: 2
- Regulation: 21 CFR 880.6860
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
36 later devices descend from it; 5 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) STERRAD® 50 Sterilization System: named in the summary without a submission number
- (no number) STERRAD® 100S Sterilization System: named in the summary without a submission number
- (no number) STERRAD® 200 Sterilization System: named in the summary without a submission number

## Most influential descendants
- K102330: Amsco V-Pro Max Low Temperature Sterilization System (2011), 21 descendants of its own
- K071385: Sterrad 100NX Sterilizer (2007), 19 descendants of its own
- K112760: Amsco V-Pro Max Low Temperature Sterilization System (2011), 18 descendants of its own
- K111377: Sterrad (R) 100NX Sterilizer Duo Cycle (2012), 17 descendants of its own
- K120632: Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization System (2012), 17 descendants of its own

## Recalls of this device
- Jan 9, 2017 · Class II · Z-1197-2017: Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during system reboot for a
- Nov 4, 2014 · Class II · Z-0845-2015: Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen 
- Dec 16, 2013 · Class II · Z-0744-2014: Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from S
- Nov 11, 2013 · Class II · Z-0403-2014: 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
- Jun 19, 2012 · Class III · Z-2338-2012: Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on the Sterrad System cassettes was inadverten
- Mar 9, 2009 · Not classified · Z-1420-2009: ASP has identified a secondary, lower-occurring cause of oil mist within certain STERRAD NX Systems and STERRAD 50 Systems due to potentially defective oil fill plugs.
- Dec 10, 2008 · Not classified · Z-0468-2012: Advanced Sterilization Products (ASP) has discovered a defect in the barcode labeling of the STERRAD NX System Cassettes 10133, Lot #08I032. This is the only lot number affected by this action. The ba
- Oct 7, 2008 · Not classified · Z-0484-2009: ASP has discovered a component defect in some of the UV lamp power supplies used in certain STERRAD NX Sterilizers. This defect can potentially cause the Hydrogen Peroxide Monitor to give inaccurate r
- Feb 25, 2008 · Not classified · Z-1631-2008: 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."
- Nov 12, 2007 · Not classified · Z-0844-2008: Outdated Compatibility Lists: Recalling firm has decided to discontinue dissemination of Compatible Medical Device Reference Lists and instrument assessment activities

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

Source page: https://510kreport.com/device/K042116
Methodology: https://510kreport.com/methodology