The record · by year · 11 years
The device record by year of decision
1614 devices, 1995 to 2026. A year with 10 or more decisions has a page of its own; the earlier years, when FDA authorized a handful a year, are rows below.
Retrieved from FDA's list, openFDA and MAUDE.
Years with 10 or more decisions
- 2026 · 132 companies181
- 2025 · 247 companies335
- 2024 · 182 companies235
- 2023 · 161 companies226
- 2022 · 116 companies162
- 2021 · 104 companies129
- 2020 · 87 companies114
- 2019 · 68 companies80
- 2018 · 62 companies65
- 2017 · 26 companies27
- 2016 · 17 companies18
The year is the year of FDA’s decision on the submission, from openFDA’s record. Devices whose decision date is not stated are listed as undated.
Earlier and undated decisions, 42 devices
Years with fewer than 10 AI-enabled devices authorized. These are the rows; each links the device page, the product code and FDA's database entry.
| Decision | Device | Company | Panel | Product code | FDA |
|---|---|---|---|---|---|
| Dario Blood Glucose Monitoring SystemK150817 · 510(k) | LabStyle Innovations Ltd. | Clinical Chemistry | NBW | database entry | |
| SnoreSoundsK150102 · 510(k) | APPIAN MEDICAL, INC. | Anesthesiology | MNR | database entry | |
| Personalized Physiology Analytics Engine softwarK142512 · 510(k) | VGBio, Inc (DBA PhysIQ) | Cardiovascular | PLB | database entry | |
| Brainscope Ahead 200K143643 · 510(k) | BRAINSCOPE COMPANY, INC. | Neurology | PIW | database entry | |
| EndoTool SubQK142918 · 510(k) | MONARCH MEDICAL TECHNOLOGIES | Anesthesiology | NDC | database entry | |
| IRIS INTELLIGENT RETINAL IMAGING SYSTEMK141922 · 510(k) | INTELLIGENT RETINAL IMAGING SYSTEMS, LLC | Radiology | NFJ | database entry | |
| BrainScope Ahead 100DEN140025 · De Novo | BRAINSCOPE COMPANY, INC | Neurology | PIW | database entry | |
| QUANTRAK142037 · 510(k) | HOLOGIC, INC. | Radiology | LLZ | database entry | |
| Lung Density AnalysisK141069 · 510(k) | IMBIO LLC | Radiology | JAK | database entry | |
| CVI42K141480 · 510(k) | CIRCLE CARDIOVASCULAR IMAGING INC | Radiology | LLZ | database entry | |
| HEPATIC VCARK133649 · 510(k) | GE MEDICAL SYSTEMS SCS | Radiology | JAK | database entry | |
| YSIO MAXK133259 · 510(k) | SIEMENS MEDICAL SOLUTIONS USA, INC. | Radiology | KPR | database entry | |
| MALDI BIOTYPER CAK130831 · 510(k) | BRUKER DALTONICS, INC | Microbiology | PEX | database entry | |
| SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICK131044 · 510(k) | DIACOUSTIC MEDICAL DEVICES (PTY) LTD. | Cardiovascular | DQD | database entry | |
| VITEK MSDEN130013 · De Novo | BIOMERIEUX, INC. | Microbiology | PEX | database entry | |
| UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEMK120771 · 510(k) | BECKMAN COULTER, INC. | Hematology | GKZ | database entry | |
| CLEARREAD +CONFIRMK123526 · 510(k) | RIVERAIN TECHNOLOGIES | Radiology | LLZ | database entry | |
| DUNE MEDICAL DEVICES MARGINPROBE SYSTEMP110014 · PMA | Dilon Medical Technologies, Ltd. | General and Plastic Surgery | OEE | database entry | |
| SENSICARDIACK121617 · 510(k) | DIACOUSTIC MEDICAL (PTY) | Cardiovascular | DQD | database entry | |
| TISSUE OF ORIGIN TEST KIT FFPEK120489 · 510(k) | PATHWORK DIAGNOSTICS, INC. | Clinical Toxcicology | OIW | database entry | |
| ALPHAPOINT IMAGING SOFTWAREK120161 · 510(k) | RADLOGICS, INC. | Radiology | LLZ | database entry | |
| DELTAVIEW MODEL 2.1K111776 · 510(k) | RIVERAIN MEDICAL GROUP,LLC | Radiology | LLZ | database entry | |
| MELAFINDP090012 · PMA | STRATA SKIN SCIENCES, INC. | General and Plastic Surgery | OYD | database entry | |
| CELLAVISION DM1200 WITH THE BODY FLUID APPLICTIOK102778 · 510(k) | CELLAVISION AB | Hematology | JOY | database entry | |
| PATHWORK TISSUE OF ORIGIN TEST KIT-FFPEK092967 · 510(k) | PATHWORK DIAGNOSTICS | Clinical Toxcicology | OIW | database entry | |
| EASYCELL CELL LOCATORK092116 · 510(k) | MEDICA CORP. | Hematology | JOY | database entry | |
| CELLAVISION DM96 WITH THE BODY FLUID APPLICATIONK080595 · 510(k) | CELLAVISION AB | Hematology | JOY | database entry | |
| QUANTRAK082483 · 510(k) | HOLOGIC, INC. | Radiology | LLZ | database entry | |
| PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TESTK080896 · 510(k) | PATHWORK DIAGNOSTICS, INC. | Clinical Toxcicology | OIW | database entry | |
| VISENSIAK081140 · 510(k) | OBS MEDICAL | Cardiovascular | MHX | database entry | |
| IB NEURO, VERSION 1.0K080762 · 510(k) | IMAGING BIOMETRICS, LLC | Radiology | LNH | database entry | |
| LUMA CERVICAL IMAGING SYSTEMP040028 · PMA | SPECTRA SCIENCE | Obstetrics and Gynecology | MWM | database entry | |
| BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUK043341 · 510(k) | BIO-RAD LABORATORIES, INC. | Clinical Toxcicology | NVI | database entry | |
| CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZERK033840 · 510(k) | CELLAVISION AB | Hematology | JOY | database entry | |
| SECOND LOOKP010034 · PMA | ICAD, INC. | Radiology | MYN | database entry | |
| RAPIDSCREEN RS-2000P000041 · PMA | RIVERAIN MEDICAL GROUP | Radiology | MYN | database entry | |
| DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZERK003301 · 510(k) | CELLAVISION AB | Hematology | JOY | database entry | |
| LOGICON CARIES DETECTORP980025 · PMA | CARESTREAM DENTAL LLC | Radiology | MYN | database entry | |
| M1000 IMAGECHECKERP970058 · PMA | Hologic, Inc. | Radiology | MYN | database entry | |
| SLEEP SYSTEM FOR CLINICS & RESEARCHK955841 · 510(k) | COMPUMEDICS PTD LTD. | Anesthesiology | MNR | database entry | |
| PAPNET Testing SystemP940029 · PMA | Neuromedical Systems, Inc. | Pathology | MNM | database entry | |
| AUTOPAPP950009 · PMA | BD DIAGNOSTICS | Pathology | NMN | database entry |
The whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.