Cleared Traditional

K000206 - PALS NEONATAL PEDIATRIC ECG ELECTRODE

K000206 is the FDA 510(k) clearance for PALS NEONATAL PEDIATRIC ECG ELECTRODE by Axelgaard Mfg. Co., Ltd.. It is a Class 2 Cardiovascular device (product code DRX) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K000206 · Axelgaard Mfg. Co., Ltd. · Cardiovascular device
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Apr 2000
Decision
83d
Days
Class 2
Risk

K000206 is an FDA 510(k) clearance for the PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Axelgaard Mfg. Co., Ltd. (Fallbrook, US). The FDA issued a Cleared decision on April 13, 2000 after a review of 83 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 Axelgaard Mfg. Co., Ltd. devices

Submission Details

510(k) Number K000206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2000
Decision Date April 13, 2000
Days to Decision 83 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
42d faster than avg
Panel avg: 125d · This submission: 83d
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 83
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