Given the 510k dataset, how do I derive the location of summary PDFs?

Question

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?

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.