Cleared Traditional

K970755 - STEALTHSHIELD

K970755 is an FDA 510(k) clearance for STEALTHSHIELD, manufactured by Vital Connections, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K970755 · Vital Connections, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
43d
Days
Class 2
Risk

K970755 is an FDA 510(k) clearance for the STEALTHSHIELD. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Vital Connections, Inc. (Tipp City, US). The FDA issued a Cleared decision on April 15, 1997 after a review of 43 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 Vital Connections, Inc. devices

FDA 510(k) Submission Details - K970755

510(k) Number K970755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1997
Decision Date April 15, 1997
Days to Decision 43 days
Submission Type Traditional
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
82d faster than avg
Panel avg: 125d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRX Device Classification - Class 2, Special Controls

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 153
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K970755.
ELECTRODE, ELECTROCARDIOGRAPH
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K970796 · 3M Healthcare · Apr 1997
EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONM
K963787 · Conmedcorp · Mar 1997
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K970125 · Contour Medical Technology, Inc. · Mar 1997