FDA applicant

Sure, Inc.

Palos Verdes Estates, CA1 decision2019–20190 recalls

FDA records 1 decision for Sure, Inc. (Palos Verdes Estates, CA) in 2019: 1 510(k) clearance. All are in product code NKA (System, Documentation, Breast Lesion). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

1in 2019

2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Sure, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sure, Inc.’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 “Sure”

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

Sure-Tech Diagnostic Associates, Inc. 1 Sure-Way Systems, Inc. 1

Sure, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Sure”