Class Class II
Tamper Evident Cap (K231095)
Description
Tamper Evident Cap by International Medical Industries, Inc., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK231095
Clearance Date2024-09-04
Clearance TypeTraditional
Product CodeFMF
Regulation Number880.5860
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K231095
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. Tamper Evident Cap (K231095) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230195 | Neo ADVISE software | Comerge AG | 2024 |
| K193192 | Tamper Evident Cap | International Medical Industries, Inc. | 2020 |
Trace the full predicate network for K231095
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.