Cleared Special

K990266 - MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE

K990266 · Micromedical Industries, Ltd. · Cardiovascular device

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Feb 1999

Decision

Days

Risk

K990266 is an FDA 510(k) clearance for the MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE.

Submitted by Micromedical Industries, Ltd. (Northfield, US). The FDA issued a Cleared decision on February 2, 1999 after a review of 5 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K990266

510(k) Number	K990266 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 28, 1999
Decision Date	February 02, 1999
Days to Decision	5 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

120d faster than avg

Panel avg: 125d · This submission: 5d

Pathway characteristics

Modification to existing cleared device.

LOS Device Classification - Class ,

Product Code	LOS
Device Class	-

Regulatory Peers - LOS

All 82

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FDA 510(k) Resources - Cardiovascular

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K990266

Micromedical Industries, Ltd.

Northfield, IL · US

DEAN E SYNDER

Regulatory profile

6 submissions 6 cleared

100% clearance rate · Active in Cardiovascular

View all devices by Micromedical Industries, Ltd. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: February 2, 1999. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: September 2026.

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