FDA applicant

Tensys Medical Systems, Inc.

San Diego, CA1 decision2012–20120 recalls

FDA records 1 decision for Tensys Medical Systems, Inc. (San Diego, CA) in 2012: 1 510(k) clearance. All are in product code DXN (System, Measurement, Blood-Pressure…). 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 Tensys Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Tensys Medical Systems, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tensys Medical Systems, 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 “Tensys”

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

Tensys Medical, Inc. 2

Tensys Medical Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Tensys”