FDA applicant

Focal Therapeutics

Portola Valley, CA5 decisions2012–20193 recalls

FDA records 5 decisions for Focal Therapeutics (Portola Valley, CA) from 2012 to 2019: 5 510(k) clearances. Most are in product codes NEU (Marker, Radiographic, Implantable) and IYE (Accelerator, Linear, Medical). Its devices cite 15 predicates, 6 of them its own earlier devices. 3 recalls are linked to its devices, 2 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Focal Therapeutics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2012high 2 (2015) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

2in 2024

2012high 2 (2024) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Focal Therapeutics by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Focal Therapeutics’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Focal”

FDA records each applicant name separately; these may or may not be the same firm.

Focal Healthcare, Inc. 1 Focal Change 1 Focal Healtcare, Inc. 1

Focal Therapeutics

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Focal”