SITCSection 7

Electrocardiographs

Name: Electrocardiographs (SITC 77411) -- U.S. Import Data
Creator: U.S. Census Bureau
License: https://www.census.gov/about/policies/open-gov/open-data.html

SITC 77411Basic heading5-digit

U.S. imports · July 2026: $28.2M; YTD $189.8M

U.S. exports · July 2026: $27.7M

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Balance · July 2026: Loading the trade balance

U.S. imports of electrocardiographs (SITC 77411) totaled $28.2M in July 2026, traded with 40 countries.

Importers of Electrocardiographs paid $1.3M in duties in July 2026 — an effective duty rate of 12% on $11.0M in dutiable value, based on actual customs collections rather than the published tariff schedule.

Last updated: July 2026 data

Electrocardiographs (ECGs or EKGs) record the electrical activity of the heart and are a foundational diagnostic tool in cardiology, emergency medicine, and primary care settings worldwide. FDA regulates imported ECG devices as Class II medical devices under 21 CFR, requiring 510(k) clearance before commercial distribution in the United States — a process that involves demonstrating substantial equivalence to a predicate device. Device features such as the number of leads (3-lead, 12-lead, 15-lead), digital connectivity, and interpretive software capabilities are key commercial differentiators that also affect regulatory classification.

AI-written summary of the official U.S. Census Bureau trade figures on this page — verify before relying on it.

1.4K shipments/mo

12-month trend

ImportsExports

Imports

$28.2MYoY · Pro

Exports

$27.7MYoY · Pro

12-mo low · imports

YoY · Pro

$37.6M$0

June 2025December 2025July 2026

Through July 2026. Source: U.S. Census Bureau.

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Basic heading 300 of 642 in section 7

Share of section 7 imports0.02%

Basic heading 77411 · $28.2M of $175.6B

Where it comes from, where it lands, what it pays

Imports · July 2026

Countries

origin

Canada and Singapore together supply 41% of it.

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Districts

customs district

Census does not publish district detail for this classification system.

States

destination

Census does not publish state detail for this classification system.

Ports

entry

Census does not publish port detail for this classification system.

Frequently Asked Questions

What FDA regulatory pathway applies to imported electrocardiographs?

Electrocardiographs are regulated by FDA as Class II medical devices. Most require 510(k) premarket notification clearance before they can be legally marketed in the US. The importer of record must ensure the device has an active 510(k) clearance and that the foreign manufacturer is registered with FDA. Devices with interpretive software may face additional scrutiny regarding the software's regulatory status as a Software as a Medical Device (SaMD).

How does lead configuration affect the commercial positioning of ECG devices in the US market?

Standard 12-lead ECGs are the clinical benchmark for full cardiac assessment and dominate hospital and clinic procurement. 3-lead and 6-lead portable devices are used in ambulatory monitoring, emergency response, and point-of-care settings. Newer devices with 15 or 18 leads offer enhanced posterior and right-ventricular views for specific indications. Buyers should confirm that the lead configuration matches the intended clinical use, as this affects both the regulatory predicate and reimbursement coding.