FDA device classification
Medical device product codes and their classification: product code, device name, class (1-3), regulation number, medical specialty, review panel, definition, submission type, implant, life-sustaining, GMP-exempt and third-party flags. Filters accept a comma list (any of the values). Pass next_page back as page; null on the last page.
With count_by=<field> the response gives facet counts of the matching records by that field instead of the records: items of {term, count} (top count_limit). Text fields count whole values on their .exact index (e.g. count_by=openfda.manufacturer_name.exact); date fields give a time series grouped by count_interval (items of {period, count}). The other filters narrow what is counted.
Every response includes credits_used: the credits this call cost.
Parameters
| name | type | description |
|---|---|---|
device | string | Words in the device name. Example: pacemaker |
product_code | string | Three-letter product code. |
device_class | 1 | 2 | 3 | u | n | f | Device class. |
regulation_number | string | Regulation number (e.g. 870.3610). |
specialty | string | Two-letter medical specialty code. |
implant | true | false | Implants only (true) or not (false). |
life_sustaining | true | false | Life-sustaining devices. |
submission_type | 510k | pma | contact_fda | 510k_exempt | enforcement_discretion | not_classified | hde | Required premarket submission. |
q | string | Free-text words; every word must appear somewhere in the record. |
search | string | An openFDA query expression added to the filters with AND, for fields the named filters do not cover (e.g. openfda.route:"TOPICAL"). |
sort | product_code | Sort field (default: relevance, or the newest first where noted). |
order | desc | asc | Sort order (default desc). |
limit | integer | Results per page. |
page | integer | Page number (1-based). Pass next_page back as page; null on the last page. |
count_by | string | Count the matching records by this field (an openFDA field name, e.g. classification.exact, openfda.brand_name.exact, or a date field). |
count_limit | integer | Number of top terms for count_by (1-1000; default 100). |
count_interval | year | month | day | Grouping of a date count_by: year (default), month or day. |
Every endpoint also takes fresh, raw, fields (see lean responses and caching).
Example
curl "https://api.api.sh/openfda/v1/devices/classification?device=pacemaker" \
-H "x-api-key: $APISH_KEY" import os, requests
res = requests.get(
"https://api.api.sh/openfda/v1/devices/classification",
params={"device": "pacemaker"},
headers={"x-api-key": os.environ["APISH_KEY"]},
timeout=120,
)
res.raise_for_status()
data = res.json() const url = new URL("https://api.api.sh/openfda/v1/devices/classification");
url.searchParams.set("device", "pacemaker");
const res = await fetch(url, { headers: { "x-api-key": process.env.APISH_KEY } });
if (!res.ok) throw new Error(`${res.status} ${await res.text()}`);
const data = await res.json(); Response
A JSON object with the fields described above, plus raw (the source's own data), cached, fetched_at and credits_used. Errors return {"success": false, "error": "…"} with the HTTP status (see errors). A lookup that ran but found nothing (404) costs the price above; refused calls and errors on our side are free (what's charged).