# K231893: LOWTEM Crystal 120

- Pathway: 510(k) (Traditional)
- Applicant: Lowtem Co., Ltd.
- Decided: Sep 18, 2024 after 448 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 K020875 (2003). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062297: VHP 136 Low Temperature Sterilization System, STERIS Corporation (2007) Summary page 5.
- K102330: Amsco V-Pro Max Low Temperature Sterilization System, STERIS Corporation (2011) Summary page 5.

## Indications for use
The LOWTEM Crystal 120 Sterilizer System is indicated to sterilize pre-cleaned and dried reusable medical devices with nonabsorbable materials. The Crystal 120 sterilizer’s Standard cycle can sterilize: * Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors, * Medical devices with single stainless-steel lumen with: An inside diameter of 1mm or larger and a length of 125mm or shorter An inside diameter of 2mm or larger and a length of 250mm or shorter An inside diameter of 3mm or larger and a length of 400mm or shorter ※ The validation testing for this lumen size was conducted using a maximum of 20 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. - Contra-indication: It is contraindicated to sterilize single usable medical devices and devices made up with absorbable materials such as cellulose or wood. - Intended user: trained nurse level or higher level of healthcare providers The validated maximum load conditions Total weight: The validation performances were conducted using a validation load consisting of two instrument trays containing a total weight of 8.9kg(19.6lbs). Usage of sterilization pouch: The medical devices to be sterilized are packaged in Tyvek sterilization pouch and sealed. The pouched medical devices are placed at the trays.

Source page: https://510kreport.com/device/K231893
Methodology: https://510kreport.com/methodology