Devices descending from K993637
715 later devices reach N-395 Pulse Oximeter, with Extended Device Claims through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +10 | K250151 | Us2.ca | Eko.Ai Pte Ltd. D/B/A Us2.Ai | 2025 | 0 | — |
| +10 | K243866 | InVision Precision Cardiac Amyloid | InVision Medical Technology Corporation | 2025 | 0 | — |
| +10 | K242518 | Hypertension Prediction Index (HePI) Algorithm | Edwards Lifesciences, LLC | 2025 | 0 | — |
| +10 | K230842 | SignalHF (IM008) | Implicity, Inc. | 2023 | 0 | — |
| +10 | K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced… | Edwards Lifesciencess, LLC | 2023 | 6 | 2 |
| +10 | K223865 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid… | Edwards Lifesciences, LLC | 2023 | 7 | — |
| +10 | K230057 | Acumen Hypotension Prediction Index (HPI) Algorithm | Edwards Lifesciences, LLC | 2023 | 5 | — |
| +10 | K223651 | Cerebral Adaptive Index (CAI) Algorithm | Edwards Lifesciences, LLC | 2023 | 6 | — |
| +10 | K223765 | ATEC Lateral Navigation Instruments | Alphatec Spine, Inc. | 2023 | 0 | 2 |
| +10 | K221203 | AHI System | Fifth Eye, Inc. | 2022 | 0 | — |
| +10 | K212271 | smart-sync | Northh Medical GmbH | 2022 | 0 | — |
| +10 | K182900 | 3880 MRI Patient Monitoring System | Iradimed Corporation | 2018 | 0 | — |
| +11 | K242909 | FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors | Edwards Lifesciences, LLC | 2025 | 0 | — |
| +11 | K240596 | Cerebral Autoregulation Index (CAI) Algorithm | Edwards Lifesciences | 2024 | 0 | — |
| +11 | K233984 | Acumen Assisted Fluid Management (AFM) Software Feature | Edwards Lifesciences, LLC | 2024 | 0 | — |