search_device510k

Tool of Scite

Search FDA 510(k) premarket notification clearances from the scite device database. Use this tool to find medical device clearances by device name, product code, applicant, clearance type, or K number. Returns clearances with device details, decision info, applicant information, and regulatory classifications. 510(k) is the FDA's premarket notification process -- manufacturers must demonstrate that their device is substantially equivalent to a legally marketed device before it can be sold. **Parameters:** - q: Search query string (device name, product code, applicant, K number, etc.) - f: Space-delimited filters in `field:"value"` format (e.g. `device.deviceClass:"2" decision.decisionCode:"SESE"`) - p: Page number (default: 1) - s: Sort field (default: _relevance). Options: - _relevance: relevance score (sortDir ignored) - device.device_class: device risk classification - device.date_received: date FDA received the submission - decision.decision_date: date of FDA decision - sortDir: Sort direction, asc or desc (default: desc). Ignored when s is _relevance. **Returns:** Device 510(k) clearances with kNumber, title, summaryText, device info (name, class, productCode, clearanceType, regulationNumber), decision info (code, description, date, committee), applicant details, and tags. **Note:** This tool returns structured clearance metadata only. For the actual narrative content of 510(k) summary documents (test results, substantial equivalence reasoning, indications for use, performance data), use `search_510k_summaries` instead.