# K023290: Sterrad 50 & Sterrad 100S Sterilizers

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Apr 3, 2003 after 183 days
- Product code: FLF (Sterilizer, Ethylene-Oxide Gas)
- Device class: 2
- Regulation: 21 CFR 880.6860
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K981625 (1999). 2 ancestors in all.
18 later devices descend from it; 1 cites 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)
- K981625: Sterrad 50 Sterilizer, Advanced Sterilization Products (1999) Summary page 1.
- K991999: Sterrad 100S Sterilizer, Advanced Sterilization Products (2000) Summary page 1.

## Most influential descendants
- K111377: Sterrad (R) 100NX Sterilizer Duo Cycle (2012), 17 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
- K153392: STERIZONE  VP4  Sterilizer (2016), 4 descendants of its own

## Recalls of this device
- Nov 4, 2014 · Class II · Z-0842-2015: 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 
- Nov 4, 2014 · Class II · Z-0843-2015: 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
- Dec 16, 2013 · Class II · Z-0745-2014: 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
- Dec 16, 2013 · Class II · Z-0746-2014: 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
- Mar 9, 2009 · Not classified · Z-1419-2009: 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.
- Oct 17, 2008 · Not classified · Z-0340-2009: 1) Inability of the sterilizer to detect when an injection takes place without hydrogen peroxide being transferred to the vaporizer bowl. This situation can result in a cycle completion with the injec
- Feb 25, 2008 · Not classified · Z-1629-2008: 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."
- Feb 25, 2008 · Not classified · Z-1628-2008: 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
This Premarket Notification is to expand the Indications for Use for the STERRAD 50 Sterilizer (K981625) and the STERRAD 100s Sterilizer (K991999) to include titanium as a compatible material and to expand the lumen sizes to include medical devices with only a single stainless steel lumen in the following configurations: An inside diameter of 1 mm or larger and a length of 125 mm or shorter An inside diameter of 2 mm or larger and a length of 250 mm or shorter The validation testing for these two new lumen sizes was conducted using a maximum of 10 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. For information pertaining to previously cleared materials and lumen sizes, please reference K981625 and K991999.

Source page: https://510kreport.com/device/K023290
Methodology: https://510kreport.com/methodology