Cleared Traditional

K242102 - CerroZone Mini (FDA 510(k) Clearance)

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

K242102 · Cerrozone, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
124d
Days
Class 2
Risk

K242102 is an FDA 510(k) clearance for the CerroZone Mini. Classified as Cleaner, Air, Medical Recirculating (product code FRF), Class II - Special Controls.

Submitted by Cerrozone, LLC (Maryland Heights, US). The FDA issued a Cleared decision on November 19, 2024 after a review of 124 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5045 - 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 Cerrozone, LLC devices

Submission Details

510(k) Number K242102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2024
Decision Date November 19, 2024
Days to Decision 124 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 128d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRF Cleaner, Air, Medical Recirculating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5045
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 - FRF Cleaner, Air, Medical Recirculating

All 52
Devices cleared under the same product code (FRF) and FDA review panel - the closest regulatory comparables to K242102.
Biomoneta Avata Rx
K251872 · Biomoneta Research Private Limited · Nov 2025
Airdog X8 Air Purifier (KJ800F-X8)
K240696 · Suzhou Beiang Smart Technology Co., Ltd. · Jun 2024
MA-40, MA-112
K223835 · Medify Air, LLC · Sep 2023
RIA Safeguard
K222416 · Ria Tech Co., Ltd. · May 2023
Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)
K211507 · Beiang Air Tech , Ltd. · Nov 2022
Qorda QD1
K220990 · Winix, Inc. · Sep 2022