# K190005: Sterilucent HC 80TT Hydrogen Peroxide Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Sterilucent, Inc.
- Decided: Sep 13, 2019 after 254 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.
No later device cites it as a predicate yet.
0 of 4 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.

## Indications for use
The Sterilucent HC 80TT Hydrogen Peroxide 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. The two pre-programmed sterilization cycles, the Lumen Cycle and the Flexible Cycle, operate at low pressure and low temperature and are thus suitable for processing medical devices that are sensitive to heat and moisture. The HC 80TT Lumen Cycle can sterilize: o Lumen and non-lumen medical devices with diffusion-restricted spaces or mated surfaces such as the hinged portion of forceps and scissors; o Single or dual channeled rigid and semi-rigid endoscopes, with stainless steel Iumens that are: • 2: 0.77 mm internal diameter(ID) and :S 410 mm long, or • 2: 1.33 mm ID and :S 430 mm long; and, o Triple channeled rigid and semi-rigid endoscopes, with stainless steel Iumens that are: • 2: 1.00 mm ID and :S 310 mm long. The validation testing for all lumen sizes was conducted using a maximum of fifteen (15) Iumens per load. Hospital loads should not exceed the maximum number oflumens validated by this testing. The validation studies were performed using two (2) separate validation loads as described in the following table. 1 Excluding the weight of the wrap. The HC 80TT Flexible Cycle can sterilize: • Rigid or semi-rigid non-lumen medical devices including non-lumen devices with metallic diffusion-restricted spaces such or mated surfaces such as the hinged portion of forceps or scissors; • Single channel flexible endoscopes with flexible Iumens that are: • 2: 1.00 mm ID and :S 1280 mm long; and, • Dual channel flexible endoscopes with flexible Iumens that are: • 2: 0.80 mm ID and :S 1000 mm long. The validation studies were performed using four (4) separate validation loads as described in the following table.

Source page: https://510kreport.com/device/K190005
Methodology: https://510kreport.com/methodology