510(k) · Cleared

Cleared

Mobile Particulate Contamination Control System, Model M-100

K023693510(k) TraditionalCleared Mar 12, 2003131-day reviewClass II21 CFR 880.5045

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Airex, Inc. · FRF Cleaner, Air, Medical Recirculating

Cleared on Mar 12, 2003 as substantially equivalent to K974682 (Biological Controls, Inc., 1998) after a 131-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.

Decided: Mar 12, 2003
Review: 131 days
Class: Class II
Product code: FRF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K974682 (1998). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK974682 Microcon 800M, Microcon 400M, Microcon Exc, Microcon EX, Microcon…Biological Controls, Inc. · 1998
This deviceK023693 Mobile Particulate Contamination Control System, Model M-100Airex, Inc. · 2003
Descendant · cites it directly · 0 of its ownK072185 Airistar Air Purification System, Model 500 & 1000Airistar Technologies, LLC · 2008

Most influential descendants

Showing 1 of 1 · See all

K072185Airistar Air Purification System, Model 500 & 1000Airistar Technologies, LLC · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K974682	Microcon 800M, Microcon 400M, Microcon Exc, Microcon EX, Microcon Wallmap	Biological Controls, Inc.	1998	—
0 (this device)	K023693	Mobile Particulate Contamination Control System, Model M-100	Airex, Inc.	2003	—
+1	K072185	Airistar Air Purification System, Model 500 & 1000	Airistar Technologies, LLC	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K023693, 1998–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K974682	Microcon 800M, Microcon 400M, Microcon Exc, Microcon EX, Microcon Wallmap Summary page 1 …from the air for medical purposes 7. Predicate Device: The M-I00 is substantially equivalent to the Micron 800M Air Purifier system by Biological Controls Inc (K974682, January23, 1998) in its design and its intended use. 8. Device Description: The M-100 is a portable HEPA-Filtered dean h…	Biological Controls, Inc.	1998	—

Also cleared against K974682: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K072185	Airistar Air Purification System, Model 500 & 1000	Airistar Technologies, LLC	2008	0

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?

Its one ancestor has no recall.
Of its descendants, K072185 (Airistar Technologies, LLC, 2008) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K974682.

How does its category compare?

All FRF devices

FRF Cleaner, Air, Medical Recirculating: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRF

1in 2025

2007high 3 (2022) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRF

163in 2022

2007high 163 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRF

1in 2012

2007high 1 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FRF

3in 2013

2007high 3 (2008) · low 0 (2009)2025

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 M-300 system is intended for use in fllterlng airborne particles from air for medical purposes.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023693 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023693: Mobile Particulate Contamination Control System, Model M-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023693

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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