Class Class II
Huxley SANSA Home Sleep Apnea Test (1000-00) (K240285)
Description
Huxley SANSA Home Sleep Apnea Test (1000-00) by Huxley Medical, an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240285
Clearance Date2024-07-15
Clearance TypeTraditional
Product CodeMNR
Regulation Number868.2375
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240285
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. Huxley SANSA Home Sleep Apnea Test (1000-00) (K240285) cites 4 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220095 | ANNE Sleep | Sibel, Inc. | 2022 |
| K212153 | Biobeat Platform, BB-613WP Patch | Biobeat Technologies , Ltd. | 2022 |
| K203343 | Wesper Lab | Wesper, Inc. | 2021 |
| K183559 | WatchPAT ONE | Itamar Medical , Ltd. | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243092 | AcuPebble Ox (200) | Acurable Limited | 2025 |
| K244027 | SANSA HSAT | Huxley Medical | 2025 |
Trace the full predicate network for K240285
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.