FDA applicant

Echo Ultrasound

Lewistown, PA6 decisions1985–19930 recalls

FDA records 6 decisions for Echo Ultrasound (Lewistown, PA) from 1985 to 1993: 6 510(k) clearances. Most are in product codes DXK (Echocardiograph) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). 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 Echo Ultrasound’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Echo Ultrasound since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Echo Ultrasound’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Echo”

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

Echo Laboratories, Inc. 4 Echo IQ, Ltd. 1 Echo Medical, LLC 1

Echo Ultrasound

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Echo”