Class Class II
Omnifix Syringe NRFit (K241385)
Description
Omnifix Syringe NRFit by B.Braun Medical, Inc., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241385
Clearance Date2024-07-13
Clearance TypeTraditional
Product CodeQEH
Regulation Number880.5860
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241385
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. Omnifix Syringe NRFit (K241385) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K071459 | B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SY... | B.Braun Medical, Inc. | 2007 |
Trace the full predicate network for K241385
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.