Class Class II
LOWTEM Crystal 120 (K231893)
Description
LOWTEM Crystal 120 by Lowtem Co., Ltd., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK231893
Clearance Date2024-09-18
Clearance TypeTraditional
Product CodeMLR
Regulation Number880.6860
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K231893
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. LOWTEM Crystal 120 (K231893) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K102330 | AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM | STERIS Corporation | 2011 |
| K062297 | VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM | STERIS Corporation | 2007 |
Trace the full predicate network for K231893
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.