510(k) · Cleared
ClearedCerroZone Mini
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cerrozone, LLC · FRF Cleaner, Air, Medical Recirculating
Cleared on Nov 19, 2024 as substantially equivalent to K220298 (Cerrozone, 2022) after a 124-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Nov 19, 2024
- Review
- 124 days
- Class
- Class II
- Product code
- FRF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K972064 (1997). No later device cites it as a predicate yet.
- Root · 4 generations backK972064 Microcon 800MUV, Microcon 400MUV, Microcon Exc-BuvBiological Controls, Inc. · 1997
- 3 generations backK070722 Plasmair, Model T2006Airinspace B.V. · 2007
- 2 generations backK200321 Novaerus NV1050Novaerus Us, Inc. · 2020
- 1 generation backK220298 CerroZone MobileCerrozone · 2022
- This deviceK242102 CerroZone MiniCerrozone, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K972064 | Microcon 800MUV, Microcon 400MUV, Microcon Exc-Buv | Biological Controls, Inc. | 1997 | — |
| −3 | K070722 | Plasmair, Model T2006 | Airinspace B.V. | 2007 | — |
| −2 | K200321 | Novaerus NV1050 | Novaerus Us, Inc. | 2020 | — |
| −1 | K220298 | CerroZone Mobile | Cerrozone | 2022 | — |
| 0 (this device) | K242102 | CerroZone Mini | Cerrozone, LLC | 2024 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FRF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRF device
- #1 K200321 Novaerus NV1050score 9.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K220298 | CerroZone MobileSummary page 5…e CerroZone Mini is substantially equivalent to the following predicate: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K220298 CerroZone Mobile / CerroZone LLC DEVICE DESCRIPTION The CerroZone Mini is a medi… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 10.0 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All FRF devicesFRF Cleaner, Air, Medical Recirculating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · FRF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRF
163in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRF
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRF
3in 2013
MAUDE reports naming product code FRF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 3 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 3 | 163 | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CerroZone Mini is intended as a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles (i.e., bacteria and viruses) from the air for medical purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242102: CerroZone Mini.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242102
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026