Medical devices

1Description

US medical device regulatory records: 510(k) clearances with predicates and indications for use, device classifications and product codes, establishment registrations, recalls and adverse event reports. Records share product codes, K numbers and firm identifiers, so a device type can be followed from clearance to later recalls. Regulatory affairs teams use it for predicate searches, quality teams for post-market surveillance, and investors and ML teams for safety signal analysis.

Subsets

• FDA establishment registrations
• Device classifications
• Recalls
• Adverse events
• 510(k) summaries

2Schema

3Sample records

Sample record 1

{
  "record_type": "510(k) premarket notification",
  "k_number": "K250031",
  "device_name": "Amplatzer Guidewire",
  "applicant": "ABBOTT MEDICAL",
  "applicant_country": "US",
  "date_received": "2025-01-07",
  "decision_date": "2025-10-03",
  "decision": "Substantially Equivalent",
  "clearance_type": "Traditional",
  "product_code": "DQX",
  "device_class": "2",
  "regulation_number": "21 CFR 870.1330",
  "classification_name": "Wire, Guide, Catheter",
  "advisory_committee": "Cardiovascular",
  "predicate_devices": [
    "Pre-Formed Guidewire, K151244"
  ],
  "reference_devices": [
    "Cardiovascular and Vascular Guidewires, K935170",
    "PTFE Guidewire, K242824"
  ],
  "indications_for_use": "The Amplatzer Guidewire is intended to facilitate the introduction and exchange of a delivery system or catheter within the vasculature and chambers of the heart.",
  "device_description": "The Amplatzer Guidewire is 0.035-inch in diameter and made of a stainless steel core and a full length stainless steel spring coil coated with low-friction polytetrafluoroethylene (PTFE). The stainless steel core extends to the distal tip of the guidewire for one model (9-GW-001). Two models (9-GW-002 and 9-GW-003) have a stainless steel core that does not extend to the distal end of the wire. These models have an additional ribbon wire that runs parallel to the stainless steel core and extends to the distal end of the guidewire. The stainless steel core for all three models is tapered at the ...",
  "summary_pdf_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250031.pdf",
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250031"
}

Sample record 2

{
  "record_type": "Device recall",
  "recall_number": "Z-0346-2025",
  "recall_class": "Class II",
  "recalling_firm": "Cook Incorporated",
  "firm_country": "United States",
  "product_description": "Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW",
  "product_code": "DQX",
  "device_class": "2",
  "regulation_number": "21 CFR 870.1330",
  "classification_name": "Wire, Guide, Catheter",
  "related_510k": [
    "K171897"
  ],
  "affected_models": [
    {
      "part_number": "CMW-14-190-12G",
      "udi_di": "00827002507876"
    },
    {
      "part_number": "CMW-14-190-18G",
      "udi_di": "00827002507883"
    },
    {
      "part_number": "CMW-14-190-25G",
      "udi_di": "00827002507890"
    },
    {
      "part_number": "CMW-14-190-6G",
      "udi_di": "00827002507869"
    },
    {
      "part_number": "CMW-14-300-12G",
      "udi_di": "00827002507913"
    },
    {
      "part_number": "CMW-14-300-18G",
      "udi_di": "00827002507920"
    },
    {
      "part_number": "CMW-14-300-25G",
      "udi_di": "00827002507937"
    },
    {
      "part_number": "CMW-14-300-6G",
      "udi_di": "00827002507906"
    }
  ],
  "affected_lot_count": 111,
  "reason_for_recall": "Affected device lots have labels that state the incorrect expiration dates.",
  "root_cause": "Labeling Change Control",
  "firm_action": "On October 8, 2024, the firm notified affected consignees through Urgent Medical Device Recall letters. Customers were informed of the product issue and instructed to quarantine any affected product that remains unused. Product should be returned to Cook Medical.",
  "product_quantity": "2,005 US; 1,145 OUS",
  "distribution_pattern": "Worldwide - US Nationwide distribution.",
  "recall_initiated": "2024-10-08",
  "posted_by_fda": "2024-11-08",
  "recall_status": "Open, Classified",
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=210545"
}

4Uses

• Predicate device searches for 510(k) submissions
• Post-market surveillance and recall monitoring
• Competitive intelligence on device clearances
• Supplier and quality risk scoring
• Safety signal detection models

6Access

The full Medical devices dataset (MLC-0403), records on request. Delivered as JSONL, CSV or Parquet under a commercial licence.

Request the full dataset