Cleared Traditional

K211194 - Molekule Air Pro

K211194 is an FDA 510(k) clearance for Molekule Air Pro, 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 121-day FDA review.

K211194 · Molekule, Inc. · General Hospital
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Aug 2021
Decision
121d
Days
Class 2
Risk

K211194 is an FDA 510(k) clearance for the Molekule Air Pro. 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 August 20, 2021 after a review of 121 days - within the typical 510(k) review window.

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 - K211194

510(k) Number K211194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2021
Decision Date August 20, 2021
Days to Decision 121 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
8d faster than avg
Panel avg: 129d · This submission: 121d
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

Hymann, 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 K211194.
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AEROCURE-MD
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