Data / FDA device clearances / De Novo (dual track)

FDA De Novo (dual track) decisions: 43 since Nov 2024

The full list. FDA De Novo (dual track) decisions: 43 rows for $5, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 1 row a month. The new rows come each week by email, $19 a month.

Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (contact, pathway, device name, applicant address, decision type, date received and 6 more), which open on your screen as soon as the payment clears and come by email. The weekly rows run until you cancel, from the link in each delivery.

For agents and scripts: this list is ordered at https://specstream.ai/data/fda-clearances/decision/de-novo-dual-track, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 27, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).

FDA made 43 device decisions of type De Novo (dual track) from November 19, 2024 to October 27, 2026: 43 510(k) clearances and De Novo grants and 0 PMA approvals and supplements, for 27 applicants. The newest, K261379 on October 27, 2026, is BD Veritor System for SARS-CoV-2 from BD Diagnostic Solutions / Becton, Dickinson & Company.

The request: Every new FDA De Novo (dual track) decision, with the applicant, its address, the device and the product code. $10 of credit on sign-up, no card.

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

• 43Decisions
• 43510(k) and De Novo
• 0PMA
• October 27, 2026Latest decision

Newest decisions

The newest 43 of 43, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

Applicants with the most decisions

By panel

By state or country

Where FDA publishes these decisions

• FDA 510(k) database
• FDA PMA database
• openFDA device API

CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.