Cleared Traditional

K911990 - ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEAD...

K911990 is the FDA 510(k) clearance for ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEAD... by Somnitec, Inc.. It is a Class 2 Cardiovascular device (product code DRX) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K911990 · Somnitec, Inc. · Cardiovascular device
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Jun 1991
Decision
46d
Days
Class 2
Risk

K911990 is an FDA 510(k) clearance for the ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT.. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Somnitec, Inc. (Van Nuys, US). The FDA issued a Cleared decision on June 21, 1991 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Somnitec, Inc. devices

Submission Details

510(k) Number K911990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1991
Decision Date June 21, 1991
Days to Decision 46 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 125d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRX Electrode, Electrocardiograph

All 45
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