# K030429: Sterrad 200 Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Aug 18, 2003 after 189 days
- Product code: MLR (Sterilizer, Chemical)
- Device class: 2
- Regulation: 21 CFR 880.6860
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 1 cites it directly.
0 of 12 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 100s Sterilization System: named in the summary without a submission number

## Most influential descendants
- 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
- K160903: STERRAD 100NX Sterilizer with ALLClearTM Technology (2016), 4 descendants of its own
- K212174: STERRAD 100NX Sterilizer with ALLClear Technology (2021), 3 descendants of its own
- K234082: STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077) (2024), 2 descendants of its own

## Recalls of this device
- Nov 4, 2014 · Class II · Z-0844-2015: 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 
- Sep 18, 2013 · Class II · Z-0043-2014: Advanced Sterilization Products (ASP) is recalling the STERRAD 200 Sterilization System because it may emit an odor or smell into the surrounding environment that is not typical to normal operating co
- Mar 22, 2013 · Class II · Z-1027-2013: 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
- Mar 13, 2012 · Class II · Z-0998-2013: Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can potentially become dislodged when an excessive load is applied.
- Jan 23, 2012 · Not classified · Z-0741-2012: ASP determined that an internal filter in the vacuum pump on the STERRAD 200 System is subject to wear over time.
- Feb 25, 2008 · Not classified · Z-1630-2008: 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

## Indications for use
The STERRAD® 200 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. The STERRAD® 200 Sterilizer can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. Medical devices with only a single stainless steel lumen with the following dimensions can be processed in the STERRAD® 200 Sterilizer. 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* An inside diameter of 3 mm or larger and a length of 400 mm or shorter Teflon® and polyethylene lumen instruments with inside diameters of 6 mm or larger and lengths of 310 mm or shorter can be processed in the STERRAD® 200 Sterilizer. *The validation testing for this lumen size was conducted using a maximum of 12 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. Note: The validation studies for this sterilizer were performed using the STERRAD cycle consisting of a 6-minute 45-second injection phase followed by a 2-minute diffusion phase and a 2-minute plasma phase. The validation studies were performed using a validation load consisting of four instrument trays each weighing 9.12 lbs. (the total weight of the load was 36.48 lbs.).

Source page: https://510kreport.com/device/K030429
Methodology: https://510kreport.com/methodology