Cleared Traditional

K200500 - Molekule Air Pro RX

K200500 is an FDA 510(k) clearance for Molekule Air Pro RX, manufactured by Molekule, Inc.. The device is a Class 2 General Hospital device with product code FRA cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K200500 · Molekule, Inc. · General Hospital
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K200500

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.

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 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.

Regulatory Peers - FRA Purifier, Air, Ultraviolet, Medical

All 26
Devices cleared under the same product code (FRA) and FDA review panel - the closest regulatory comparables to K200500.
Molekule Air Mini, Molekule Air Mini +
K202339 · Molekule, Inc. · Feb 2021
AEROCURE-MD
K203189 · Aerobiotix, Inc. · Jan 2021
Aerus Medical Guardian,model F170A
K201220 · Aerus Medical, LLC · Jun 2020
Transformair Indoor Air Purifier
K161468 · Transformair, LLC · Feb 2017
ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE DISINFECTION UNITS, ODOROX(R) SLIMLINE/RX (TM) SLIMLI
K133800 · Hgi Industires · Dec 2014
ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400
K062716 · Eco-Rx, Inc. · Oct 2006