# K991999: Sterrad 100S Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Jun 15, 2000 after 367 days
- Product code: MLR (Sterilizer, Chemical)
- Device class: 2
- Regulation: 21 CFR 880.6860
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 2 cite it directly.
0 of 20 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® 100 Sterilization System: named in the summary without a submission number
- (no number) STERRAD® 50 Sterilization System: named in the summary without a submission number

## Most influential descendants
- K023290: Sterrad 50 & Sterrad 100S Sterilizers (2003), 18 descendants of its own
- 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

## Recalls of this device
- Jun 19, 2012 · Class III · Z-2337-2012: 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
- 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-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."
- Nov 12, 2007 · Not classified · Z-0844-2008: Outdated Compatibility Lists: Recalling firm has decided to discontinue dissemination of Compatible Medical Device Reference Lists and instrument assessment activities
- Nov 12, 2007 · Not classified · Z-0845-2008: User Guide Update: based on user reports about contact with residual hydrogen peroxide from instruments, pouches and trays after sterilization and subsequent light colored residue on these devices aft
- Sep 16, 2005 · Not classified · Z-0197-06: The STERRAD 100 and the STERRAD 100S vaporizer plates are prone to displacement allowing micro-droplets of H2O2 to contact the load. If the vaporizer plate is dislodged, there is an increased chance f

## Indications for use
The STERRAD® 100S Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. Because the cycle operates within a dry environment and at low temperatures, it is especially suitable for instruments sensitive to heat and moisture. (See list of recommended Materials in Section 3 of the Operator’s Manual.) The STERRAD® 100S Sterilizer can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. Metal and nonmetal lumened instruments with inside diameters of 6 mm or larger and lengths of 310 mm or shorter can be processed in the STERRAD® 100S Sterilizer. (See list of recommended Materials in Section 3 of the Operator’s Manual) Medical devices with only a single stainless steel lumen which has an inside diameter equal to or greater than 3 mm and a length less than or equal to 400 mm can be processed in the STERRAD® 100S Sterilizer.

Source page: https://510kreport.com/device/K991999
Methodology: https://510kreport.com/methodology