How long does a 510(k) submission take to get cleared?

Is the 90-day timeline always the case? Don't confuse FDA device submission decision timelines with the actual review timeline in calendar days. The best way to estimate the FDA review timelines is to look at actual review times for other devices in your product classification.
In this video, Rob Packard demonstrates how to do this search using Basil Systems software to do the search.
➤ basilsystems.com/
For our search, we only used the period of 2012 to 2023 because the introduction of the FDA’s RTA policy in 2012 added more time to most submission review timelines. We also limited our search to Traditional Type 510(k) submissions instead of Special 510(k) submissions and Abbreviated 510(k) submissions. Our search results are summarized below:
FLL - clinical thermometer = 339 devices and 295-day average review timeline
FRO - dressing = 255 devices and 209-day average review timeline
LCX - pregnancy test = 34 devices and 201-day average review timeline
If you want to know what the average review timeline is for your device, please contact us for a free introductory meeting:
➤ medicaldevicea...

[@Peaceseeker917]

I would like to sell Derma roller that have needle sizes over 0.3mm. Amazon won't let me sell it unless I have 510k clearance. Can I get cleared for this product?

[@MedicalDeviceAcademy]

This is very common. We see companies selling products from other countries that the FDA requires 510(k) clearance for. The problem is that the devices require the testing data before the FDA will clear it. The testing for biocompatibility can cost as much as our preparation of the 510(k). Cleaning validation can cost even more, and you also have to pay the FDA user fee.

[@Peaceseeker917]

How much roughly do you think it will cost?