510(k) Report

FDA applicant

Compass Medical Technologies, Inc.

Minneapolis, MN1 decision1992–19920 recalls

FDA records 1 decision for Compass Medical Technologies, Inc. (Minneapolis, MN) in 1992: 1 510(k) clearance. All are in product code LIL (Monitor, Penile Tumescence). No recall is linked to its devices.

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

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

FDA decisions per year

No FDA decision for Compass Medical Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • LILMonitor, Penile Tumescence1decision

What has FDA decided for it lately?

  • K925931RT2 Rigidity and Tumescence TestCompass Medical Technologies, Inc. · 1992

The one decision as Compass Medical Technologies, Inc. →

Other applicant names beginning “Compass”

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

Compass Intl., Inc. 2Compass Bioscience 2