Your 510(k) Could be Delayed by 12 Months

A LinkedIn survey shows that most regulatory professionals would have saved 12 months on their first 510(k) if they had an real example.


Start moving up the waitlist today

Share with friends, earn points, & move up!


Why Share?

You can get earlier access than the general public, discounts, and even a free license!



Sharing is caring.

You would be bummed If one of your connections knew about this and kept it to themselves. Right?



The greater good.

The more interest we gather, the lower the price we will be able to negotiate with the sponsor and the more sponsors we can convince to do the same in the future.


10
10
Early Access
Early Access
20
20
10% Discount
10% Discount
200
200
20% Discount
20% Discount
1000
1000
A FREE License
A FREE License

3

your place in line

6

points earned

9

total waitlist members

Everyone has templates but nobody has concrete examples. 


Don't miss out on this QIH example 510(k)

Don't delay your submission. Get the PDFs we submitted to FDA for this recently cleared AI/ML SaMD 510(k)


We built and cleared it in 12 months.

Don't Miss Out On

Presubmission

The request, written feedback, slides, minutes, and more

510(k) eSTAR Docs

The eSTAR PDF we sent to FDA and all PDFs

AINN Letter + Response + Clearance Letter

The FDA's AINN (Hold) letter and the response

Word Templates

As an optional addon, we give you access to the empty Word templates so you can prepare your own 510(k) application

The Goods

Get all the PDFs sent to and from FDA including the full submission. 

The Team

Whats even better than an example 510(k)? Hire the dream team.

Our Services

Engineering


Clinical Studies


Trusted By

FAQs

Is it really everything?

We redacted the names of the FDA reviewers for privacy but otherwise everything is included. 

Why is it not released yet?

We still need to tidy up the contract with the sponsor to allow us to distribute the example 510(k)

When will it be released?

Likely within the next two months. Sooner if we get a lot of sign ups. So sign up and tell your network.

How much will it be?

The higher the number of sign ups, the lower the price can be to properly compensate the sponsor. So sign up and share. We are negotiating the details with the sponsor. 

Will it be free?

Aside from a monthly give-away for the top referrers, no. A 510(k) is a lot of work and we want to ensure the sponsors are properly compensated for their generosity.

Why has this not been done before?

510(k)s are expensive and require a multidisciplinary team that typically only exist at for-profit companies that do not have an incentive to share. Innolitics, has the multidisciplinary team and a strong case to share

Will you have startup or open source pricing?

Only if there is enough interest from the startup, open source, and academic community. So please share!

Are there any limitations?

The terms of service will have a clause that prohibits creating a competing product. The sponsor has a patent to protect the technology.