Kem Medical Lead-free Chemical Indicators for Steam Sterilization (K241836)
Description
Kem Medical Lead-free Chemical Indicators for Steam Sterilization by Kem Medical Products Corporation, an FDA 510(k) cleared general hospital device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241836
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. Kem Medical Lead-free Chemical Indicators for Steam Sterilization (K241836) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K101528 | 3M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM | 3M Company | 2010 |
Trace the full predicate network for K241836
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.