> ## Documentation Index
> Fetch the complete documentation index at: https://docs.rhizomeai.com/llms.txt
> Use this file to discover all available pages before exploring further.

# 510(k) / Denovo

> Search filters and result fields of fda_denovo_or_510k.

* **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.

## Filters

Send these under `filters.fda_denovo_or_510k` in a [search](/api-reference/v3/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.

<ParamField body="device_name" type="string">
  Keyword match on device name (BM25 tokenized, case-insensitive). Example: 'continuous glucose monitor'.
</ParamField>

<ParamField body="company" type="string">
  Keyword match on company/applicant name (BM25 tokenized, case-insensitive). Example: 'OxiMed'.
</ParamField>

<ParamField body="submission_kind" type="string">
  Filter by submission family. denovo = DEN\* prefixed knumbers, 510k = K\* prefixed knumbers. Omit to include both.

  Values: `denovo`, `510k`.
</ParamField>

<ParamField body="knumber" type="string">
  Exact submission number match (normalized to uppercase). Examples: 'K123456', 'DEN220045'.
</ParamField>

<ParamField body="product_code" type="string">
  Exact FDA product code match (normalized to uppercase). Examples: 'LRK', 'QAS'.
</ParamField>

<ParamField body="date_decision_from" type="string (date)">
  Inclusive lower bound on decision date (YYYY-MM-DD). Example: '2026-01-01' for 'this year'.
</ParamField>

<ParamField body="date_decision_to" type="string (date)">
  Inclusive upper bound on decision date (YYYY-MM-DD). Example: '2024-12-31'.
</ParamField>

## Fields

Each result from this dataset has these in `fields`:

`company`, `date_decision`, `date_received`, `device_name`, `knumber`, `product_code`, `url`


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