The De Novo process provides a pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device. De Novo classification is a risk-based classification process.
Devices that are classified into class I or class II through a De Novo classification request may be marketed and used as predicates for future premarket notification [510(k)] submissions.
| Manufacturer | Device Name | Date | |
|---|---|---|---|
| Mucosal Integrity Conductivity (MI) Test System | 2019-12-23 | ||
| Control-IQ Technology | 2019-12-13 | ||
| GSP Neonatal Creatine Kinase - MM Kit | 2019-12-12 | ||
| Cobas VivoDx MRSA | 2019-12-05 | ||
| WOUNDCHEK Bacterial Status | 2019-12-02 | ||
| EchoTip Insight Portosystemic Pressure Gradient Measuring System | 2019-11-20 | ||
| OraQuick Ebola Rapid Antigen Test | 2019-10-10 | ||
| IB-Stim | 2019-06-07 | ||
| Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit | 2019-05-23 | ||
| ZIKV Detect 2.0 IgM Capture ELISA | 2019-05-23 | ||
| Nerivio Migra | 2019-05-20 | ||
| Comaneci, Comaneci Petit, Comaneci 17 | 2019-04-24 | ||
| PREVENA 125 And PREVENA PLUS 125 Therapy Units | 2019-04-19 | ||
| Monarch ETNS System | 2019-04-19 | ||
| Plenity | 2019-04-12 | ||
| LOADPRO™ Intraoperative Rod Strain Sensor | 2019-03-28 | ||
| Leica FL400 | 2019-03-28 | ||
| ClearMate | 2019-03-14 | ||
| Quantra Hemostasis Analyzer, QPlus Cartridge | 2019-03-12 | ||
| Early Bird Bleed Monitoring System | 2019-03-01 | ||
| T:slim X2 Insulin Pump With Interoperable Technology | 2019-02-14 | ||
| Aptima Mycoplasma Genitalium Assay | 2019-01-23 | ||
| EyeBOX | 2018-12-28 | ||
| MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe K | 2018-12-21 | ||
| Miris Human Milk Analyzer | 2018-12-21 | ||
| SEM Scanner (Model 200) | 2018-12-20 | ||
| Enlight 1810 | 2018-12-20 | ||
| Retrograde Intubation Set | 2018-12-12 | ||
| Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit | 2018-11-30 | ||
| QMS Plazomicin Immunoassay | 2018-11-19 | ||
| Innovo | 2018-11-06 | ||
| Parathyroid Detection (Model PTeye) System | 2018-11-02 | ||
| Fluobeam 800 Clinic Imaging Device Used With Fluocase 800 Control System | 2018-11-02 | ||
| 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | 2018-10-31 | ||
| PicoAMH ELISA | 2018-10-24 | ||
| Bose Hearing Aid | 2018-10-05 | ||
| Adaptive Biotechnologies ClonoSEQ Assay | 2018-09-28 | ||
| NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET | 2018-09-21 | ||
| Irregular Rhythm Notification Feature | 2018-09-11 | ||
| ECG App | 2018-09-11 | ||
| MATRx Plus | 2018-08-23 | ||
| Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System | 2018-08-17 | ||
| Natural Cycles | 2018-08-10 | ||
| MolecuLight I:X | 2018-07-31 |