Cleared Traditional

K003937 - CPR EZY MASK AND PAD

K003937 is an FDA 510(k) clearance for CPR EZY MASK AND PAD, manufactured by Medteq Innovations Pty, Ltd.. The device is a Class 2 Cardiovascular device with product code LIX cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K003937 · Medteq Innovations Pty, Ltd. · Cardiovascular device
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Jun 2001
Decision
168d
Days
Class 2
Risk

K003937 is an FDA 510(k) clearance for the CPR EZY MASK AND PAD. Classified as Aid, Cardiopulmonary Resuscitation (product code LIX), Class II - Special Controls.

Submitted by Medteq Innovations Pty, Ltd. (Rockville, US). The FDA issued a Cleared decision on June 6, 2001 after a review of 168 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5210 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medteq Innovations Pty, Ltd. devices

FDA 510(k) Submission Details - K003937

510(k) Number K003937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2000
Decision Date June 06, 2001
Days to Decision 168 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 125d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIX Device Classification - Class 2, Special Controls

Product Code LIX Aid, Cardiopulmonary Resuscitation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5210
Definition Cpr Aid Device With Feedback (visual, Audio Or Both) On One Or More Cpr Parameters (e.g., Rate, Depth, Ventilation Ratio, Etc.), And Contains Software. Provides Real-time Feedback On Cpr Performance. Feedback Can Be Audio, Visual Or Both. Device Contains Software
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.