Evaluation of Automatic Class III Designation

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.

Latest De Novo Classifications

ManufacturerDevice NameDate
APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System2022-07-12
ProdiGI2022-06-13
BioFire Joint Infection (JI) Panel2022-04-29
CavaClear Laser Sheath2021-12-21
Paige Prostate2021-09-21
Canary Tibial Extension With Canary Health Implanted Reporting Processor (CHIRP) System2021-08-27
SureTune4 Software2021-08-23
ADVIA Centaur Enhanced Liver Fibrosis (ELF)2021-08-20
OsteoProbe2021-08-19
InSpace Subacromial Tissue Spacer System2021-07-12
Cognoa ASD Diagnosis Aid2021-06-02
SafeBreak Vascular2021-05-27
Portable Neuromodulation Stimulator (PoNS)2021-03-26
BioFire Respiratory Panel 2.1 (RP2.1)2021-03-17
Analytic For Hemodynamic Instability (AHI)2021-03-01
Hominis Surgical System2021-02-26
Lumenis Stellar M222021-02-23

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