# K981625: Sterrad 50 Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Jan 11, 1999 after 249 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
No predicates in its family tree.
19 later devices descend from it; 1 cites 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) STERI-VAC Gas Sterilizer Model 5XL: 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
- 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.
- Jan 12, 2009 · Not classified · Z-1570-2009: The capacitor in the vacuum pump component within the Sterrad 50 System could overheat and potentially create a hazardous condition inside the system, resulting in smoke and/or fire.
- 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."
- Nov 12, 2007 · Not classified · Z-0844-2008: Outdated Compatibility Lists: Recalling firm has decided to discontinue dissemination of Compatible Medical Device Reference Lists and instrument assessment activities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® 50 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® 50 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 (% inch) or larger and lengths of 310 mm (12 inches) or shorter can be processed in the STERRAD® 50 Sterilizer. (See list of recommended Materials in Section 3 of the Operator’s Manual.) Additionally, medical devices with only a single stainless steel lumen which has an inside diameter of 3 mm (1/8 inch) or larger and a length of 400 mm (15 34 inches) or shorter can be processed in the STERRAD® 50 Sterilizer.

Source page: https://510kreport.com/device/K981625
Methodology: https://510kreport.com/methodology