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

$29.8MU.S. imports · April 2026SITC 77411

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SITCSection 7

Electrocardiographs

$29.8MU.S. imports · April 2026SITC 77411

U.S. imports of electrocardiographs (SITC 77411) totaled $29.8M in April 2026, traded with 32 countries.

Importers of Electrocardiographs paid $1.2M in duties in April 2026 — an effective duty rate of 12% on $10.0M in dutiable value, based on actual customs collections rather than the published tariff schedule.

Last updated: April 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.

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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.

U.S. imports of electrocardiographs (SITC 77411) totaled $29.8M in April 2026, traded with 32 countries.

Importers of Electrocardiographs paid $1.2M in duties in April 2026 — an effective duty rate of 12% on $10.0M in dutiable value, based on actual customs collections rather than the published tariff schedule.

Last updated: April 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.

Imports: $29.8M; from 32 countries
Exports: $34.8M
Trade balance: Surplus of $4.9M; net exporter

YTD $108.5M (April 2026) · 1.3K shipments/mo

Top trading partners

View all 32

Country	Imports	Exports	Balance
SINGAPORE	$7.7M	$16.6M	+$9.0M
CANADA	$9.2M	$3.7M	-$5.6M
SWITZERLAND	$2.5M	$443K	-$2.1M
MALAYSIA	$2.2M	$587K	-$1.6M
MEXICO	$1.5M	$541K	-$943K

SINGAPORE

Imports$7.7M

Exports$16.6M

Balance+$9.0M

CANADA

Imports$9.2M

Exports$3.7M

Balance-$5.6M

SWITZERLAND

Imports$2.5M

Exports$443K

Balance-$2.1M

MALAYSIA

Imports$2.2M

Exports$587K

Balance-$1.6M

MEXICO

Imports$1.5M

Exports$541K

Balance-$943K

Import Trend (12 months)

Monthly import values over time

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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.