Class Class II
VM-2000 (K240807)
Description
VM-2000 by Ventis Medical, Inc., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240807
Clearance Date2024-08-13
Clearance TypeTraditional
Product CodeCBK
Regulation Number868.5895
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240807
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. VM-2000 (K240807) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202970 | Ventway Sparrow | Inovytech Medical Solutions , Ltd. | 2021 |
| K181166 | Trilogy Evo | Respironics, Inc. | 2019 |
| K083688 | PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR | Pulmonetic Systems, Inc. | 2009 |
Trace the full predicate network for K240807
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.