CerroZone Mini

FDA 510(k) K242102 · Cerrozone, LLC

Substantially Equivalent

510(k) numberK242102

Submission

Device name
CerroZone Mini
Applicant
Cerrozone, LLC
Maryland Heights, MO, US
Received
July 18, 2024
Decision date
November 19, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FRF – Cleaner, Air, Medical Recirculating
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5045
Specialty
General Hospital

Other 510(k)s with product code FRF

510(k)DeviceApplicantDecision
K251872Biomoneta Avata RxFRF · Traditional Biomoneta Research Private Limited11/14/2025SE
K240696Airdog X8 Air Purifier (KJ800F-X8)FRF · Special Suzhou Beiang Smart Technology Co., Ltd.06/14/2024SE
K223835MA-40, MA-112FRF · Traditional Medify Air, LLC09/18/2023SE
K222416RIA SafeguardFRF · Traditional Ria Tech Co., Ltd.05/01/2023SE
K211507Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)FRF · Traditional Beiang Air Tech , Ltd.11/22/2022SE
K220990Qorda QD1FRF · Traditional Winix, Inc.09/14/2022SE
K220298CerroZone MobileFRF · Traditional Cerrozone07/01/2022SE
K200321Novaerus NV1050FRF · Traditional Novaerus Us, Inc.12/28/2020SE
K130702Airsonett AIR-4FRF · Traditional Airsonett AB07/23/2013SE
K112728Hepairx Ventilating Air PurifierFRF · Traditional Air Innovations, Inc.01/23/2013SE

More from Air Innovations, Inc.

510(k)DeviceDecision
K220298CerroZone MobileFRF · Traditional 07/01/2022SE

Questions and answers

When was CerroZone Mini cleared by the FDA?

CerroZone Mini (K242102) received a 510(k) decision of Substantially Equivalent on November 19, 2024, 124 days after the submission was received.

What is the product code of K242102?

The FDA product code is FRF – Cleaner, Air, Medical Recirculating, a Class II (moderate risk) device regulated under 21 CFR 880.5045.