I think if the company wants to be successful, they need to take the regulatory submission process seriously and not embellish how similar a device is to a predicate device. Substantial equivalence means that the new device is at least as safe and effective as the predicate, a legally U.S. marketed device. As per the FDA website to be considered substantially equivalent in comparison to a predicate it:

“has the same intended use as the predicate; and
has the same technological characteristics as the predicate;
or
has the same intended use as the predicate; and
has different technological characteristics and does not raise different questions of safety and effectiveness; and
the information submitted to FDA demonstrates that the device is at least as safe and effective as the legally marketed device.”

The new and predicate device do not have to be identical but substantial equivalence can be established with respect to intended use, design, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility,etc. I would expect a company to provide the true information when submitting to the FDA, if they have plans to be a successful company. Trying to pull a fast one on the FDA isn’t the smartest idea because they can perform inspections and audits and the ultimately the truth will come out sooner or later. A device cant marketed in the U.S. until the submitter receives a letter declaring the device substantially equivalent from the FDA. If FDA determines that a device is not substantially equivalent, the applicant can resubmit a 510(k) with new data, go through the DeNovo Classification process, file a reclassification petition, or submit a PMA.

Overall, I think its in the company’s best interest to act in an ethical manner. Trying to submit a fraudulent 501k notice to avoid class III Premarket approval processes, may seem like a route to save the company money and time to get to market, but ultimately it could cost them everything with being shut down by the FDA in the long run for a fraudulent submission.