Cleared Traditional

Bluezone Model RX-450 Air Purifier (K212824) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K212824 · Bluezone Products, Inc. · General Hospital
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Feb 2022
Decision
167d
Days
Class 2
Risk

K212824 is an FDA 510(k) clearance for the Bluezone Model RX-450 Air Purifier. Classified as Purifier, Air, Ultraviolet, Medical (product code FRA), Class II - Special Controls.

Submitted by Bluezone Products, Inc. (Woburn, US). The FDA issued a Cleared decision on February 17, 2022 after a review of 167 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Bluezone Products, Inc. devices

Submission Details

510(k) Number K212824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2021
Decision Date February 17, 2022
Days to Decision 167 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 129d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

O'Connell Regulatory Consultant, Inc.
Maureen O'Connell

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FRA Purifier, Air, Ultraviolet, Medical

All 17
Devices cleared under the same product code (FRA) and FDA review panel - the closest regulatory comparables to K212824.
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