# K212200: STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette

- Pathway: 510(k) (Traditional)
- Applicant: Plasmapp Co,., Ltd.
- Decided: Oct 22, 2021 after 100 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: 3 generations back to K062297 (2007). 3 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140464: Sterilucent PSD-85 Hydrogen Peroxide Sterilizer, Sterilucent, Inc. (2014) Summary page 5.

## Most influential descendants
- 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) (2023), 0 descendants of its own
- K223015: STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette (2023), 0 descendants of its own
- K220345: STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) (2023), 0 descendants of its own

## Indications for use
The STERLINK™ FPS-15s 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™ FPS-15s 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.

Source page: https://510kreport.com/device/K212200
Methodology: https://510kreport.com/methodology