Having ingested the 510k dataset, several of the entries have a statement_or_summary value of "Summary" or "Statement" which I understand means a summary/statement is available.

For example, given this record:

  "third_party_flag": "N",
  "advisory_committee_description": "Ear, Nose, Throat",
  "statement_or_summary": "Summary",
  "product_code": "ETN",
  "openfda": {
    "device_name": "Stimulator, Nerve",
    "medical_specialty_description": "Ear, Nose, Throat",
    "regulation_number": "874.1820",
    "device_class": "2",
    "registration_number": [...],
    "fei_number": [...]
  "applicant": "THE MAGSTIM COMPANY LTD.",
  "decision_date": "1995-06-02",
  "decision_code": "SESE",
  "device_name": "NEUROSIGN 100 IMPEDANCE METER",
  "advisory_committee": "EN",
  "contact": "CHRIS  HOVEY",
  "expedited_review_flag": "",
  "k_number": "K945799",
  "date_received": "1994-11-28",
  "decision_description": "Substantially Equivalent",
  "clearance_type": "Traditional"

Although the record says "Summary", one doesn't exist when viewing the FDAs database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K945799

So far I've seen that the URL structure for these is normally https://www.accessdata.fda.gov/cdrh_docs/pdf<k number year>/<k number>.pdf However, for years 95ish through 01ish, it's just /pdf/ with no year. Is this behavior documented anywhere (or possibly purposely not exposed)? Is there something I'm missing?

1 Answer 1


openFDA renders its 510K dataset from the downloadable 510K files, which unfortunately do not provide any information about the links to PDF letters. We would recommend that you contact CDRH directly to inquiry about the best way of programmatically obtaining the links to PDFs.

  • 1
    Yeah I was afraid this would be the answer, which is fine. I'll contact the CDRH and see what they say. thank you for your answer; as its probably the most correct one ill get here, ill accept it.
    – castis
    Mar 22, 2021 at 15:22
  • @castis Could you probably post the answer you got from the CDRH here? I think that would be very helpful for many people. Thank you!
    – captcoma
    Apr 3, 2021 at 20:43
  • Unfortunately, for many items with a entry in statement_or_summary there is no PDF available from the FDA (see also here)
    – captcoma
    Dec 18, 2022 at 22:20

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