FDA applicant

Shape Memory Medical

Santa Clara, CA2 decisions2018–20190 recalls

FDA records 2 decisions for Shape Memory Medical (Santa Clara, CA) from 2018 to 2019: 2 510(k) clearances. All are in product code KRD (Device, Vascular, For Promoting Embolization). Its devices cite 5 predicates, 1 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, cardiovascular panel, where it files most

How often FDA has decided Shape Memory Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2018high 1 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Shape Memory Medical by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shape Memory Medical’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 “Shape”

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

Shape Medical Systems, Inc. 2 Shape Products Co. 1

Shape Memory Medical

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Shape”