i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) (K222727)
Description
i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) by I3 Membrane GmbH, an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222727
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. i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) (K222727) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K182164 | Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filt... | Ecolab, Inc. | 2019 |
| K153434 | Pall-Aquasafe Water Filter | Pall International Sarl | 2016 |
Trace the full predicate network for K222727
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.