FDA applicant

Twin Star Medical, Inc.

Minnetonka, MN4 decisions2004–20140 recalls

FDA records 4 decisions for Twin Star Medical, Inc. (Minnetonka, MN) from 2004 to 2014: 4 510(k) clearances. All are in product code LXC (Monitor, Pressure, Intracompartmental). Its devices cite 7 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Twin Star Medical”.

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

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

FDA decisions per year

1in 2014

2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Twin Star Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Twin Star Medical, 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 “Twin”

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

Twin City Surgical, Inc. 6 Twin Falls Orthopedic Associates, P.A. 1

Twin Star Medical, Inc.

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?

Other applicant names beginning “Twin”