Class Class II
Fetal & Maternal Monitor (F15A, F15A Air) (K241882)
Description
Fetal & Maternal Monitor (F15A, F15A Air) by Edan Instruments, Inc., an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241882
Clearance Date2025-08-27
Clearance TypeTraditional
Product CodeHGM
Regulation Number884.2740
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241882
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. Fetal & Maternal Monitor (F15A, F15A Air) (K241882) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K173042 | Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Exp... | Edan Instruments, Inc. | 2018 |
Trace the full predicate network for K241882
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.