FDA 510(k) & De Novo Medical Device Clearances B2B Lead Intelligence Scraper

100% Entity-Pure Relational LEFT JOIN MedTech Lead Engine (1 Row = 1 Recently Cleared FDA 510(k) Submission) enriched across 5 Authoritative Public APIs for Immediate Import into Instantly.ai, Smartlead, Clay.com, Orum/Nooks, and HubSpot/Salesforce.

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1. Who Buys This Data & How They Use It

When a medical device manufacturer receives FDA 510(k) Clearance (SESE), an immediate 30-to-90-day commercial execution window opens. The company must transition from regulatory review into commercial manufacturing, sterile packaging, GUDID/UDI labeling, hospital supply-chain onboarding, and post-market surveillance.

Target Paying Buyer Personas

1. Medical Device Contract Manufacturers (CMOs / CDMOs) & Sterilization / Packaging Vendors:
   • Filter by applicant_total_510k_clearances_num <= 5 (EMERGING_MEDTECH_ENTRANT) or establishment_role = "Develop Specifications But Do Not Manufacture At This Facility" to identify specification developers and emerging MedTech companies that outsource production, molding, and EO/gamma sterilization.
2. QA/RA Regulatory & Post-Market Surveillance (PMS) Consultants:
   • Filter by review_days_num > 180 (EXTENDED_MULTI_ROUND_REVIEW) or category_maude_adverse_events_num >= 5000 (HIGH_SCRUTINY_DEVICE_CATEGORY) to pitch 21 CFR Part 820 QMSR audits, MDR complaint handling, and EU MDR transition support directly to the named 510(k) regulatory correspondent.
3. MedTech 3PL Logistics, GPO Contracting & Hospital Distribution Agencies:
   • Filter by applicant_country != "US" (CH, DE, GB, IL, TW, BR, KR) or commercial_distribution_status to target foreign MedTech manufacturers that just cleared FDA review and need US 3PL warehousing, importer representation, and IDN/GPO hospital sales teams.
4. Vertical B2B SaaS SDRs (eQMS, UDI Compliance, Clinical/ERP Software):
   • Import contact_first_name, contact_last_name, contact_email, company_clean_name, company_domain, and outreach_icebreaker directly into Instantly.ai, Smartlead, or Clay.com; dial contact_phone_e164 in Orum / Nooks using cold_call_opening_hook.

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2. Relational LEFT JOIN Architecture (Zero UNION ALL)

Unlike raw openFDA scrapers that dump unjoined ALL-CAPS records without domains, emails, phones, or facility registrations, every row represents 1 Recently Cleared FDA 510(k) Submission (k_number) enriched via 4 relational LEFT JOIN steps:

Join Step	Authoritative Data Source	Join Key	Enriched Fields & Derived Signals
Base Entity	openFDA 510(k) Clearances API (api.fda.gov/device/510k.json)	k_number	k_number, submission_type, date_received, decision_date, review_days_num, review_speed_tier, device_clean_name, product_code, medical_specialty, device_class_num, regulation_number, split contact_first_name & contact_last_name
LEFT JOIN 1	openFDA Historical Portfolio API (api.fda.gov/device/510k.json?search=applicant:...)	applicant / core_search_name	applicant_total_510k_clearances_num, medtech_commercial_stage_signal (EMERGING_MEDTECH_ENTRANT vs. GROWTH_STAGE_MEDTECH vs. ENTERPRISE_MEDTECH_OEM)
LEFT JOIN 2	openFDA Establishment Registration & UDI/GUDID APIs (registrationlisting.json + udi.json)	Verified registration.name / owner_operator.firm_name / company_name	fda_registration_number, fda_fei_number, owner_operator_number, establishment_role, udi_public_device_records_num, commercial_distribution_status, official correspondent phone & GUDID customer contact email/phone
LEFT JOIN 3	openFDA MAUDE Adverse Event & Recall APIs (event.json + recall.json)	product_code	category_maude_adverse_events_num, category_recalls_num, post_market_surveillance_risk_tier
LEFT JOIN 4	FDA GUDID + Clearbit Autocomplete Domain Resolution	Verified brand tokens	company_clean_name, company_domain, company_website_url, contact_email, email_resolution_source, fda_us_agent_email, contact_phone_e164, contact_phone_formatted

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3. Complete 48-Column Output Schema (7-Gate Buyer-Ready Standard)

Field	Type	Description
k_number	string	Primary entity key: Official FDA 510(k) or De Novo clearance number (e.g., K262080)
submission_type	string	Traditional 510(k), Special 510(k), Dual Track 510(k), or De Novo Classification
decision_code	string	FDA decision code (e.g., SESE)
decision_description	string	Official FDA clearance determination (Substantially Equivalent)
date_received	string	ISO YYYY-MM-DD date FDA received the submission
decision_date	string	ISO YYYY-MM-DD date FDA issued clearance
review_days_num	string	Pure numeric calendar days in FDA review (e.g., 123)
review_speed_tier	string	Derived review friction tier (FAST_TRACK_CLEARANCE, STANDARD_FDA_REVIEW, EXTENDED_MULTI_ROUND_REVIEW)
company_clean_name	string	Clean Title Case company name stripped of Inc., LLC, GmbH, AG, Ltd. for cold email merge tags
applicant_legal_name	string	Official FDA applicant legal entity name
company_domain	string	Verified root domain (e.g., cascination.com, globusmedical.com)
company_website_url	string	Full HTTPS company website URL
device_clean_name	string	Human-readable Title Case device name stripped of SKU lists, catalog codes, and symbols
device_raw_name	string	Original proprietary device name string filed with FDA
product_code	string	3-letter FDA product classification code
medical_specialty	string	FDA Advisory Committee medical specialty panel
device_class_num	string	Pure numeric FDA risk class (1, 2, or 3)
device_risk_class	string	Formatted risk class (Class I, Class II, Class III)
regulation_number	string	21 CFR citation (e.g., 892.2050)
contact_first_name	string	Clean Title Case first name of the official 510(k) regulatory contact
contact_last_name	string	Clean Title Case last name of the official 510(k) regulatory contact
contact_full_name	string	Full human name of the official 510(k) correspondent
contact_credentials	string	Extracted credentials (PhD, MD, RAC) or None Listed
contact_role_title	string	Official 510(k) Regulatory Correspondent
contact_email	string	Single atomic email resolved via FDA GUDID, FDA Registration, or verified corporate domain
email_resolution_source	string	Provenance of contact_email
fda_us_agent_email	string	Official FDA-registered US Agent email for foreign manufacturers
contact_phone_e164	string	E.164 phone number (+16109301800, +41313062653)
contact_phone_formatted	string	Human-readable formatted phone ((610) 930-1800)
applicant_street_address	string	Street address of the applicant facility
applicant_city	string	Applicant city
applicant_state	string	2-letter US state or international region code
applicant_zip	string	Applicant postal / ZIP code
applicant_country	string	2-letter ISO country code (US, CH, GB, DE, IL, TW, BR)
applicant_total_510k_clearances_num	string	LEFT JOIN 1: Total lifetime FDA 510(k) clearances held by this applicant
medtech_commercial_stage_signal	string	LEFT JOIN 1: Derived commercial stage signal
fda_registration_number	string	LEFT JOIN 2: Verified FDA Establishment Registration Number
fda_fei_number	string	LEFT JOIN 2: Verified FDA Establishment Identifier (FEI)
owner_operator_number	string	LEFT JOIN 2: Verified FDA Owner/Operator Number
establishment_role	string	LEFT JOIN 2: Registered establishment role (Manufacture Medical Device, Specification Developer)
udi_public_device_records_num	string	LEFT JOIN 2: Count of published GUDID/UDI device records
commercial_distribution_status	string	LEFT JOIN 2: GUDID commercial distribution status
category_maude_adverse_events_num	string	LEFT JOIN 3: Total MAUDE adverse event reports for this product_code
category_recalls_num	string	LEFT JOIN 3: Total FDA recalls for this product_code
post_market_surveillance_risk_tier	string	LEFT JOIN 3: Derived post-market surveillance risk tier
fda_summary_url	string	Direct URL to the official FDA CDRH 510(k) / De Novo record
outreach_icebreaker	string	Plug-and-play personalized cold email opening sentence
cold_call_opening_hook	string	Plug-and-play power-dialer opening script