# K223015: STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette

- Pathway: 510(k) (Traditional)
- Applicant: Plasmapp Co,., Ltd.
- Decided: May 9, 2023 after 222 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: 4 generations back to K062297 (2007). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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 5.

## Indications for use
The STERLINK™ FPS-15s Plus sterilizer 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 STERPACK™ plus: An inside diameter of 1.6 mm or larger and a length of 200 mm or shorter o STERLOAD™: 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 1 lb and 3.97 lbs with STERPACK™ plus and STERLOAD™, respectively.

Source page: https://510kreport.com/device/K223015
Methodology: https://510kreport.com/methodology