# K231169: STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) - Pathway: 510(k) (Special) - Applicant: Plasmapp Co,., Ltd. - Decided: May 25, 2023 after 30 days - Product code: MLR (Sterilizer, Chemical) - Device class: 2 - Regulation: 21 CFR 880.6860 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 5 generations back to K921910 (1993). 12 ancestors in all. No later device cites it as a predicate yet. 0 of 13 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K212200: STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette, Plasmapp Co,., Ltd. (2021) Summary page 7. - K212198: Tyvek (R) Roll with CI for STERLINKTM Sterilizer, Plasmapp Co,., Ltd. (2021) Summary page 7. - K212193: Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40), Plasmapp Co,., Ltd. (2021) Summary page 7. ## Indications for use The STERLINK Plus sterilizer with STERLOAD cassette is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed, and dried reusable metal and nonmetal medical devices used in healthcare facilities. A pre-programmed sterilization lumen cycle operates at low pressure and low temperature and is thus suitable for processing medical devices sensitive to heat and moisture. The STERLINK Plus can sterilize*: * Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors * Medical devices with a single stainless steel lumen with: o An inside diameter of 2.4 mm or larger and a length of 280 mm or shorter *The validation testing for all lumen sizes was conducted using a maximum of five (5) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load with a total weight of 3 .97 lbs. Tyvek@ Roll with CI for STERLINK Sterilizer, when used in CF BER mode, is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERLINK sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 1 month post sterilization. The materials compatibility for use in the Tyvek@ Roll with CI for STERLINK Sterilizer, when used in CH BER mode, are as follows: Aluminum 5052, Aluminum 6061, Stainless Steel 304, Stainless Steel 316L, Titanium, Acrylonitrile Butadiene Styrene (ABS), High Density Polyethylene (HPDE), Polypropylene (PP), Polytetrafluorethylene (PTFE) and Silicone (Hardness 50). The maximum load weight that can be placed in the Tyvek@ roll is: * 3.97 pounds (1.8kg) for CE BER mode of FPS-15s Plus * 3.97 pounds (1.8kg) for CE BER mode of STERLINK plus sterilizer * 1.54 pounds (0.7kg) for CHAMBER mode of STERLINK mini sterilizer The roll is printed with a chemical indicator bar which is a process indicator (ISO 11140-1 :2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINK sterilizer. The Tyvek@ Roll with CI for STERLINK Sterilizer is offered in the follow 1 type: * Sterilization roll, Flat Terragene Bionova@ SCBI (BT96) is a self-contained biological indicator inoculated with viable 10A6 Geobacillus stearothernophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. BT96 has Super Rapid readout at 30 minutes at 60'C. Terragene Bionova@ Reader Incubators (IC10/2OFRLCD, Mn-Bio) incubate at 60'C and 37 0 C and read the Terragene Bionova@ SCRI for fluorescent results at the tines prescribed in the User Maluals. Terragene Chemdyet (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. The chenuical indicator changes from red to yellow for CD42 to idicate that the conditions of the cycle have been met. Terragene Cintape@ (CT40) is a chemical process indicator tape intended for monitoring the efficacy of Vaporized Hydrogen Peroxide sterilization processes The indicating tape changes fiom purple to green when exposure to vaporized hydrogen peroxide The self-contained biological indicator and chemical processing indicators are intended for use with: *CF BER mode of FPS-15s Plus sterilizer * CF BER mode of STERLink plus sterilizer * CHAMBER mode of STERLINK Mni sterilizer Source page: https://510kreport.com/device/K231169 Methodology: https://510kreport.com/methodology