510(k) · Cleared
ClearedAiristar Air Purification System, Model 500 & 1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Airistar Technologies, LLC · FRF Cleaner, Air, Medical Recirculating
Cleared on Mar 27, 2008 as substantially equivalent to K984116 (Abatement Technologies, Inc., 1999) and 2 other predicates after a 234-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Mar 27, 2008
- Review
- 234 days
- Class
- Class II
- Product code
- FRF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K974682 (1998). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK974682 Microcon 800M, Microcon 400M, Microcon Exc, Microcon EX, Microcon…Biological Controls, Inc. · 1998
- 1 generation backK023693 Mobile Particulate Contamination Control System, Model M-100Airex, Inc. · 2003
- This deviceK072185 Airistar Air Purification System, Model 500 & 1000Airistar Technologies, LLC · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K072185 | Airistar Air Purification System, Model 500 & 1000 | Airistar Technologies, LLC | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
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? (3)
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 |
|---|---|---|---|
| * | K984116 | Hepa-Care Air Cleaner American Air Filter Air Filtration System Models HC800F, HFS800F…Summary page 1…is substantially equivalent to the following predicate devices. Hepa-Care Air Cleaner, Model HC400F & HC400E-UV by Abatement Technologies, Inc. 510(k) #: K984116 MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, Airex, Inc. 510(k) #: K023693 Advanced Air Cleaner Sys… | 1999 |
| * | K023693 | Mobile Particulate Contamination Control System, Model M-100Summary page 1…Model HC400F & HC400E-UV by Abatement Technologies, Inc. 510(k) #: K984116 MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, Airex, Inc. 510(k) #: K023693 Advanced Air Cleaner System, Healthway Products, 510(k) #: K012549… | 2003 |
| * | K012549 | Advanced Air Purification System; Hepa Air Cleaning SystemSummary page 1…MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, Airex, Inc. 510(k) #: K023693 Advanced Air Cleaner System, Healthway Products, 510(k) #: K012549 7 of 14 === Page 2 ==… | 2002 |
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 10 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All FRF devicesFRF Cleaner, Air, Medical Recirculating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Intended for use in filtering airborne particles from air for medical purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072185 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072185: Airistar Air Purification System, Model 500 & 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072185
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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