Class Class II
Atmo Gas Capsule System (K250940)
Description
Atmo Gas Capsule System by Atmo Biosciences, Ltd., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250940
Clearance Date2025-06-26
Clearance TypeTraditional
Product CodeNYV
Regulation Number876.1725
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250940
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. Atmo Gas Capsule System (K250940) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K092342 | SMARTPILL GI MONITORING SYSTEM, VERSION 2.0 | The Smartpill Corporation | 2009 |
Trace the full predicate network for K250940
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.