Cleared Traditional

K062716 - ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400

K062716 is an FDA 510(k) clearance for ECO-RX AIR PURIFIER WITH UV LIGHT, manufactured by Eco-Rx, Inc.. The device is a Class 2 General Hospital device with product code FRA cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K062716 · Eco-Rx, Inc. · General Hospital
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Oct 2006
Decision
45d
Days
Class 2
Risk

K062716 is an FDA 510(k) clearance for the ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400. Classified as Purifier, Air, Ultraviolet, Medical (product code FRA), Class II - Special Controls.

Submitted by Eco-Rx, Inc. (Quebec City, Qc, CA). The FDA issued a Cleared decision on October 27, 2006 after a review of 45 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6500 - the FDA general hospital 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 Eco-Rx, Inc. devices

FDA 510(k) Submission Details - K062716

510(k) Number K062716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2006
Decision Date October 27, 2006
Days to Decision 45 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 129d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FRA Device Classification - Class 2, Special Controls

Product Code FRA Purifier, Air, Ultraviolet, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6500
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 Hospital devices follow this clearance model.

Regulatory Peers - FRA Purifier, Air, Ultraviolet, Medical

All 22
Devices cleared under the same product code (FRA) and FDA review panel - the closest regulatory comparables to K062716.
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K972064 · Biological Controls, Inc. · Dec 1997
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