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  • Dataset id: fda_denovo_or_510k
  • Jurisdiction: US · FDA
  • Date field: date_decision. The search’s top-level date_from and date_to filter on it.
  • Access: any API key.

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Filters

Send these under filters.fda_denovo_or_510k in a search request. A filter not listed here, or a value of the wrong type, is a 400. The top-level date_from and date_to set date_decision_from and date_decision_to below, so give a date in one place only.
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string
Keyword match on device name (BM25 tokenized, case-insensitive). Example: ‘continuous glucose monitor’.
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string
Keyword match on company/applicant name (BM25 tokenized, case-insensitive). Example: ‘OxiMed’.
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string
Filter by submission family. denovo = DEN* prefixed knumbers, 510k = K* prefixed knumbers. Omit to include both.Values: denovo, 510k.
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string
Exact submission number match (normalized to uppercase). Examples: ‘K123456’, ‘DEN220045’.
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string
Exact FDA product code match (normalized to uppercase). Examples: ‘LRK’, ‘QAS’.
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string (date)
Inclusive lower bound on decision date (YYYY-MM-DD). Example: ‘2026-01-01’ for ‘this year’.
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string (date)
Inclusive upper bound on decision date (YYYY-MM-DD). Example: ‘2024-12-31’.

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Fields

Each result from this dataset has these in fields: company, date_decision, date_received, device_name, knumber, product_code, url