Cleared Traditional

K212644 - Aura Storm

K212644 is an FDA 510(k) clearance for Aura Storm, manufactured by Invictus Lighting. The device is a Class 2 General Hospital device with product code FRA cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K212644 · Invictus Lighting · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
279d
Days
Class 2
Risk

K212644 is an FDA 510(k) clearance for the Aura Storm. Classified as Purifier, Air, Ultraviolet, Medical (product code FRA), Class II - Special Controls.

Submitted by Invictus Lighting (Hickory, US). The FDA issued a Cleared decision on May 26, 2022 after a review of 279 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 Invictus Lighting devices

FDA 510(k) Submission Details - K212644

510(k) Number K212644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2021
Decision Date May 26, 2022
Days to Decision 279 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
150d slower than avg
Panel avg: 129d · This submission: 279d
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 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 K212644.
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