Cleared Traditional

Molekule Air Pro RX (K200500) - FDA 510(k) Clearance

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

K200500 · Molekule, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Apr 2020
Decision
47d
Days
Class 2
Risk

K200500 is an FDA 510(k) clearance for the Molekule Air Pro RX. Classified as Purifier, Air, Ultraviolet, Medical (product code FRA), Class II - Special Controls.

Submitted by Molekule, Inc. (San Francisco, US). The FDA issued a Cleared decision on April 15, 2020 after a review of 47 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 Molekule, Inc. devices

Submission Details

510(k) Number K200500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2020
Decision Date April 15, 2020
Days to Decision 47 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
82d faster than avg
Panel avg: 129d · This submission: 47d
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

Hyman, Phelps & McNamara, P.C.
Adrienne R. Lenz

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.