510(k) · Cleared
ClearedMicrocon 800M, Microcon 400M, Microcon Exc, Microcon EX, Microcon Wallmap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biological Controls, Inc. · FRF Cleaner, Air, Medical Recirculating
Cleared on Jan 23, 1998 after a 39-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Jan 23, 1998
- Review
- 39 days
- Class
- Class II
- Product code
- FRF
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK974682 Microcon 800M, Microcon 400M, Microcon Exc, Microcon EX, Microcon…Biological Controls, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK023693 Mobile Particulate Contamination Control System, Model M-100Airex, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK203189 Aerocure-MDAerobiotix, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK072185 Airistar Air Purification System, Model 500 & 1000Airistar Technologies, LLC · 2008
Most influential descendants
Showing 3 of 3 · See all- K023693Mobile Particulate Contamination Control System, Model M-100Airex, Inc. · 2003 · cites it directly1descendant
- K203189Aerocure-MDAerobiotix, Inc. · 2021 · cites it directly0descendants
- K072185Airistar Air Purification System, Model 500 & 1000Airistar Technologies, LLC · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974682 | Microcon 800M, Microcon 400M, Microcon Exc, Microcon EX, Microcon Wallmap | Biological Controls, Inc. | 1998 | — |
| +1 | K023693 | Mobile Particulate Contamination Control System, Model M-100 | Airex, Inc. | 2003 | — |
| +1 | K203189 | Aerocure-MD | Aerobiotix, Inc. | 2021 | — |
| +2 | K072185 | Airistar Air Purification System, Model 500 & 1000 | Airistar Technologies, LLC | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2021 | 1 | 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 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
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, K023693 (Airex, Inc., 2003) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FRF devicesFRF Cleaner, Air, Medical Recirculating: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 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/K974682 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974682: Microcon 800M, Microcon 400M, Microcon Exc, Microcon EX, Microcon Wallmap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974682
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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