PRIMED Surgical Masks and PRIMED Procedure Masks (K240286)
Description
PRIMED Surgical Masks and PRIMED Procedure Masks by Primed Medical Products, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240286
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. PRIMED Surgical Masks and PRIMED Procedure Masks (K240286) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K081633 | PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL F... | Primed Medical Products, Inc. | 2008 |
Trace the full predicate network for K240286
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.