# K140464: Sterilucent PSD-85 Hydrogen Peroxide Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Sterilucent, Inc.
- Decided: Oct 31, 2014 after 249 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: 2 generations back to K062297 (2007). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083097: Amsco V-Pro 1 Low Temperature Sterilization System, STERIS Corporation (2009) Summary page 5.

## Most influential descendants
- K212200: STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette (2021), 3 descendants of its own
- 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
- K190005: Sterilucent HC 80TT Hydrogen Peroxide Sterilizer (2019), 0 descendants of its own

## Indications for use
The Sterilucent PSD-85 Hydrogen Peroxide Sterilizer (PSD-85) 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. The two pre-programmed sterilization cycles, the Lumen and the Non-Lumen Cycles, operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture. The PSD-85 Lumen Cycle 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 1 mm or larger and a length of 60 mm or shorter o An inside diameter of 2 mm or larger and a length of 250 mm or shorter o An inside diameter of 3 mm or larger and a length of 350 mm or shorter *The validation testing for all lumen sizes was conducted using a maximum of ten (10) 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 consisting of one instrument tray with a total weight of 10.4 lbs. The PSD-85 Non-Lumen Cycle can sterilize**: • Non-lumen instruments including non-lumen instruments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors. **The validation studies were conducted using a validation load consisting of one instrument tray with a total weight of 25.3 lbs.

Source page: https://510kreport.com/device/K140464
Methodology: https://510kreport.com/methodology