Accelerated Device Approval Services ("ADAS") is the 510k consultancy with the most success, see the righthand side of this website for a list of some of our successful 510k approvals with the FDA. We are the fastest method to get your 510k cleared by the FDA.
The average 510k that we work on receives a 510k clearance from the FDA within only 95-days. One of the reasons for the quicker clearance timeline is because all our consultants have regulatory experience in each medical device sector, such as Radiology and Gastroenterology.
Please note that we are not part of the FDA´s Third-Party Review program.
1. What are the advantages of using ADAS to create the 510(k) application for your device?
On average, our clients can begin selling their device more than six months earlier than if they applied directly with the FDA.
2. What are the 510(k) Consulting Fees?
Of course, this depends on how complicated your device is. However, the average cost for us to use our consulting services $15,000.
Radiofrequency lesion probe
Electrocardiograph transmitter and receiver
Powered muscle stimulator
Electrosurgical cutting and coagulation device
Picture archiving and communications system
Wireless ECG monitoring system https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191331.pdf
Bracket adhesive resin and tooth conditioner
Compressible limb sleeve
Endoscope Accessories https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191231.pdf