Data / FDA device clearances / Pathology

FDA Pathology device clearances: 194 since Nov 2024

The full list. FDA pathology device clearances and approvals: 194 rows for $9.70, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 12 rows 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 (pathway, device name, applicant address, contact, date received, device type 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. The rows on this page are a sample.

For agents and scripts: this list is ordered at https://specstream.ai/data/fda-clearances/panel/pathology, 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 194 device decisions in pathology (FDA review panel) from November 12, 2024 to October 27, 2026: 28 510(k) clearances and De Novo grants and 166 PMA approvals and supplements, for 43 applicants. The newest, P200014/S012 on October 27, 2026, is cobas® EZH2 Mutation Test from Roche Molecular System, Inc..

The request: Every new FDA clearance or approval of a pathology device, with the applicant, its address 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.

• 194Decisions
• 28510(k) and De Novo
• 166PMA
• October 27, 2026Latest decision

Newest decisions

The newest 100 of 194, 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 decision type

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.