Class Class II
Orchid Safety Release Valve (K230266)
Description
Orchid Safety Release Valve by Linear Health Sciences, LLC, an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230266
Clearance Date2023-05-04
Clearance TypeTraditional
Product CodeQOI
Regulation Number880.5220
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230266
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. Orchid Safety Release Valve (K230266) cites 1 predicate device and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212064 | Orchid Safety Release Valve(TM) | Linear Health Sciences, LLC | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232094 | Orchid Safety Release ValveTM | Linear Health Sciences, LLC | 2023 |
| K231957 | SafeBreak® Vascular | Lineus Medical | 2023 |
Trace the full predicate network for K230266
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.