510(k) · Cleared
ClearedHepa-Care Air Cleaner American Air Filter Air Filtration System Models HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abatement Technologies, Inc. · FRF Cleaner, Air, Medical Recirculating
Cleared on Jun 24, 1999 after a 219-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jun 24, 1999
- Review
- 219 days
- Class
- Class II
- Product code
- FRF
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK984116 Hepa-Care Air Cleaner American Air Filter Air Filtration System…Abatement Technologies, Inc. · 1999
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K984116 | Hepa-Care Air Cleaner American Air Filter Air Filtration System Models HC800F… | Abatement Technologies, Inc. | 1999 | — |
| +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 |
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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072185 | Airistar Air Purification System, Model 500 & 1000 | 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?
- Of its descendants, K072185 (Airistar Technologies, LLC, 2008) has gone furthest, with 0 descendants 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 HEPA-CARE Air filtration systems are used for filtering out airborne particles from the 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/K984116 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984116: Hepa-Care Air Cleaner American Air Filter Air Filtration System Models HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984116
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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