Cleared Traditional

K202339 - Molekule Air Mini

K202339 is an FDA 510(k) clearance for Molekule Air Mini, 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 190-day FDA review.

K202339 · Molekule, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2021
Decision
190d
Days
Class 2
Risk

K202339 is an FDA 510(k) clearance for the Molekule Air Mini, Molekule Air Mini +. 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 February 23, 2021 after a review of 190 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 Molekule, Inc. devices

FDA 510(k) Submission Details - K202339

510(k) Number K202339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2020
Decision Date February 23, 2021
Days to Decision 190 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
61d slower than avg
Panel avg: 129d · This submission: 190d
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 17
Devices cleared under the same product code (FRA) and FDA review panel - the closest regulatory comparables to K202339.
CUBE Air Purifier
K211139 · Samsung Electronics Co., Ltd. · Nov 2021
Molekule Air Pro
K211194 · Molekule, Inc. · Aug 2021
EOS Air Cleaner
K202766 · Guangzhou Ajax Medical Equipment Co., Ltd. · Jun 2021
AEROCURE-MD
K203189 · Aerobiotix, Inc. · Jan 2021
Aerus Medical Guardian,model F170A
K201220 · Aerus Medical, LLC · Jun 2020
Molekule Air Pro RX
K200500 · Molekule, Inc. · Apr 2020