40 devices on the FDA's AI list came through De Novo grants, each a new device type
De Novo grants among the devices on the FDA's AI-Enabled Medical Device List, by year of the grant, 2013 to June 2026 (2026*: January to June). Each grant set up a new device type, named in the table
Show the numbers as a table
| Period | Value | Note |
|---|---|---|
| 2013 | 1 | System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates |
| 2014 | 1 | Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid |
| 2015 | 0 | None |
| 2016 | 0 | None |
| 2017 | 2 | Genetic Variant Detection And Health Risk Assessment System; Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer |
| 2018 | 7 | Radiological Computer-Assisted Triage And Notification Software; Adjunctive Predictive Cardiovascular Indicator; Diabetic Retinopathy Detection Device; Radiological Computer Assisted Detection/Diagnosis Software For Fracture; Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals; Closed Loop Auto Titration Device For Oral Appliances; Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid |
| 2019 | 0 | None |
| 2020 | 1 | Image Acquisition And/Or Optimization Guided By Artificial Intelligence |
| 2021 | 6 | Adjunctive Hemodynamic Indicator With Decision Point; Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate; Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate; Gastrointestinal Lesion Software Detection System; Pediatric Autism Spectrum Disorder Diagnosis Aid; Software Algorithm Device To Assist Users In Digital Pathology |
| 2022 | 1 | Ultrasound Guided Nerve Block Assist |
| 2023 | 6 | Adjunctive Pain Measurement Device For Anesthesiology; Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan; Monitor For Opioid Induced Impairment Of Oxygenation; Prognostic Test For Assessment Of Chronic Kidney Disease Progression; Cardiovascular Machine Learning-Based Notification Software; Gastrointestinal Capsule Endoscopy Analysis Software Device |
| 2024 | 9 | Prognostic Assessment Software Of Mild Cognitive Impairment; Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer; Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.; Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm; Over-The-Counter Device To Assess Risk Of Sleep Apnea; Software Device To Aid In The Prediction Or Diagnosis Of Sepsis; Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density; Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device; Dental Image Analyzer |
| 2025 | 2 | Radiological Software Device To Predict Future Breast Cancer Risk; Pathology Software Algorithm Device Analyzing Digital Images For Prostate Cancer Prognosis |
| 2026* | 4 | Radiological Software System For Delivery Date Prediction; Ear, Nose, And Throat Image Analyzer; Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.; Software Device System For Estimation Of Cardiac Pressures |
About the data
- Sources
- FDA, Artificial Intelligence-Enabled Medical Devices (opens in a new tab)The list (CSV), content current as of September 4, 2026: Date of Final Decision, Submission Number, Panel (Lead), Primary Product Code
- FDA, product classification file (opens in a new tab)foiclass.txt (October 26, 2026): PRODUCTCODE, DEVICENAME, DEVICECLASS
- FDA, De Novo Classification Request (opens in a new tab)What the De Novo pathway is, and what happens when a request is granted
- Method
- Kent Applied joined each device on the FDA's AI-Enabled Medical Device List (the version current as of September 4, 2026: 1,614 devices with final decisions from September 29, 1995, to June 29, 2026) to its record in the FDA's 510(k), PMA and product classification files by submission number. The FDA says the list is not a comprehensive resource of AI-enabled devices. A De Novo grant is a submission number starting DEN. The device type is the FDA's name for the product code the grant set up, from the product classification file. 2026 runs from January to June.
- Published
Free to share and embed with credit to Kent Applied (CC BY 4.0). The source data keeps its own terms.
Related charts
- From research
About one FDA 510(k) clearance in ten is now for a device on the AI list
FDA, Artificial Intelligence-Enabled Medical Devices; FDA, 510(k) releasable files - From research
More than half of the FDA's 2025 clearances tagged radiology were for AI-listed devices
FDA, Artificial Intelligence-Enabled Medical Devices; FDA, 510(k) releasable files - From research
Three in four AI-listed devices are in the radiology panel; its share peaked in 2020
FDA, Artificial Intelligence-Enabled Medical Devices - From research
AI-listed 510(k)s took a median 141 days to a decision in 2025, against 126 for all
FDA, Artificial Intelligence-Enabled Medical Devices; FDA, 510(k) releasable files; FDA, 510(k) Submission Process
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