In the device 510(k) endpoint data (downloadable JSON file on OpenFDA), a single 510(k) number is associated with multiple FDA Establishment Identification (FEI) numbers, and I am not being able to figure out how those multiple FEI numbers are associated with a single 510(k) number. I would greatly appreciate your help.

Below are some more details on how I collected/parsed the data and an example.

I have downloaded the device 510(k) endpoint data (JSON file) from the OpenFDA website (link here), and parsed it in R software, using the "jasonlite" package (R code for importing the json file below):

data_flat_510k <- fromJSON('device-510k-0001-of-0001.json', flatten = TRUE)

The device 510(k) endpoint data has 29 fields (i.e., columns), including 510(k) number, device name, applicant name and address, etc. One of these fields is "openfda.fei_number" which is a "list" of the FEI numbers associated with each 510(k) number.

For example, the list of FEI numbers associated with a single 510(k) number "K840424" is: "1048014, 3002808374, 3003915875, 3009211636, 1000587249, 2518902, 1000138054, 1282497"

So, the 510(k) number "K840424" has 8 FEI numbers. If I look this 510(k) number up in the Device Registrations and Listings database (also available/downloadable on OpenFDA), it shows only one medical device establishment, and thus, only one FEI number (which is one of the above listed FEI numbers).

Again, I can't figure out how these FEI numbers are associated with this single 510(k) number, and I would appreciate your help!

1 Answer 1


openfda is the "harmonization" record, and for medical devices harmonization revolves around product_code. So in the example you provided the 8 FEI numbers correspond to the product code of KNZ, not directly to the 510(k) number. More on this here: https://github.com/FDA/openfda/blob/master/openfda/device_harmonization/pipeline.py

Sorry about the confusion.


Your Answer

By clicking “Post Your Answer”, you agree to our terms of service and acknowledge you have read our privacy policy.

Not the answer you're looking for? Browse other questions tagged or ask your own question.