510(k) · Cleared
ClearedMicrocon 800MUV, Microcon 400MUV, Microcon Exc-Buv
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biological Controls, Inc. · FRA Purifier, Air, Ultraviolet, Medical
Cleared on Dec 1, 1997 after a 181-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.
- Decided
- Dec 1, 1997
- Review
- 181 days
- Class
- Class II
- Product code
- FRA
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK972064 Microcon 800MUV, Microcon 400MUV, Microcon Exc-BuvBiological Controls, Inc. · 1997
- Descendant · cites it directly · 6 of its ownK070722 Plasmair, Model T2006Airinspace B.V. · 2007
- Descendant · 2 generations on · 5 of its ownK200321 Novaerus NV1050Novaerus Us, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK211507 Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)Beiang Air Tech, Ltd. · 2022
- Descendant · 3 generations on · 1 of its ownK220298 CerroZone MobileCerrozone · 2022
- Descendant · 4 generations on · 0 of its ownK242102 CerroZone MiniCerrozone, LLC · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K070722Plasmair, Model T2006Airinspace B.V. · 2007 · cites it directly6descendants
- K200321Novaerus NV1050Novaerus Us, Inc. · 2020 · 2 generations on5descendants
- K211507Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)Beiang Air Tech, Ltd. · 2022 · 3 generations on1descendant
- K220298CerroZone MobileCerrozone · 2022 · 3 generations on1descendant
- K242102CerroZone MiniCerrozone, LLC · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972064 | Microcon 800MUV, Microcon 400MUV, Microcon Exc-Buv | Biological Controls, Inc. | 1997 | — |
| +1 | K070722 | Plasmair, Model T2006 | Airinspace B.V. | 2007 | — |
| +2 | K200321 | Novaerus NV1050 | Novaerus Us, Inc. | 2020 | — |
| +3 | K211507 | Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) | Beiang Air Tech, Ltd. | 2022 | — |
| +3 | K220298 | CerroZone Mobile | Cerrozone | 2022 | — |
| +4 | K242102 | CerroZone Mini | Cerrozone, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FRA? 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 FRA device
- #1 K212644 Aura Stormscore 13.9 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K070722 (Airinspace B.V., 2007) has gone furthest, with 6 descendants of its own.
How does its category compare?
All FRA devicesFRA Purifier, Air, Ultraviolet, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRA
205in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRA
No recall names FRA since 2007.
Adverse event reports per year · FRA
2in 2024
MAUDE reports naming product code FRA, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 5 | 190 | 0 | 1 |
| 2022 | 4 | 175 | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 4 | 205 | 0 | 2 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MICROCON air filtration system is used for filtering out airborne particles from air for medical purposes.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972064 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972064: Microcon 800MUV, Microcon 400MUV, Microcon Exc-Buv.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972064
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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