510(k) Report

FDA applicant

Microhelix, Inc.

Bainbridge Island, WA1 decision2004–20040 recalls

FDA records 1 decision for Microhelix, Inc. (Bainbridge Island, WA) in 2004: 1 510(k) clearance. All are in product code ITX (Transducer, Ultrasonic, Diagnostic). Its devices cite 2 predicates, 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Microhelix, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Microhelix, 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

Which product codes does it file in?

  • ITXTransducer, Ultrasonic, Diagnostic1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K040213MHLX7EC TransducerMicrohelix, Inc. · 2004

The one decision as Microhelix, Inc. →