How to select a

predicate
device
for your 510(k)
Search for
legally
marketed
devices
using the FDA 510(k)
premarket notification
database by
Name/Manufacturer of
similar devices
Product codes
510(k) Number
Filter them by
used methods
Analyse the 510(k) summary
what methods have been
used such as recognized
standards, FDA guidances, etc.

Prefer the devices used well-

established and up to date
methods.
Search for
reports
Use the MAUDE, MDR and
MedSun Reports database to
search for reports.

Prefer devices without reports

or document, how you
mitigate that risk.
Search for
safety issues
Search on the FDA website for
safety communications.

Once again: prefer devices

without safety issues or
document, how you mitigate
that risk.
Search for
recalls
Use the Medical Device Recalls
Database to search for recalls.

And again: prefer devices

without recalls or document,
how you mitigate that risk.
Document
your selection
in your 510(k)
Show your selection process in
your 510(k) submission as part
of the 510(k) Summary.
 Summary
Search for
similar
devices

Legally Marketed Devices

Filter for
Filter for Filter for
safety and Filter for
used safety
performanc recalls
methods issues
e

Valid Predicate Devices

select the
best fit

Choosen Predicate(s)
Example
of documentation out of the
Guidance.
 What are your
thoughts on this
new Guidance
from the FDA?
Leave a comment below.

Beat Keller
https://www.linkedin.com/in/beat-keller/