Cleared Traditional

K020466 - HEC 1000

K020466 is an FDA 510(k) clearance for HEC 1000, manufactured by Metro Medical Equipment, Inc.. The device is a Class 2 General & Plastic Surgery device with product code KPJ cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K020466 · Metro Medical Equipment, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
85d
Days
Class 2
Risk

K020466 is an FDA 510(k) clearance for the HEC 1000. Classified as Chamber, Oxygen, Topical, Extremity (product code KPJ), Class II - Special Controls.

Submitted by Metro Medical Equipment, Inc. (Livonia, US). The FDA issued a Cleared decision on May 8, 2002 after a review of 85 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5650 - the FDA general and plastic surgery device 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 Metro Medical Equipment, Inc. devices

FDA 510(k) Submission Details - K020466

510(k) Number K020466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2002
Decision Date May 08, 2002
Days to Decision 85 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPJ Device Classification - Class 2, Special Controls

Product Code KPJ Chamber, Oxygen, Topical, Extremity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5650
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - KPJ Chamber, Oxygen, Topical, Extremity

All 12
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