510(k) · Cleared
ClearedElectro-Optical Air Sterilizer with Ionizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
John Mfg., Ltd. · FRA Purifier, Air, Ultraviolet, Medical
Cleared on Jul 12, 2004 as substantially equivalent to K023830 (Kes Science & Technology, Inc., 2003) after a 257-day review. Its family tree reaches back 1 generation to 2003. 16 later devices descend from it.
- Decided
- Jul 12, 2004
- Review
- 257 days
- Class
- Class II
- Product code
- FRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023830 (2003). 16 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK023830 Airocide TI02Kes Science & Technology, Inc. · 2003
- This deviceK033448 Electro-Optical Air Sterilizer with IonizerJohn Mfg., Ltd. · 2004
- Descendant · cites it directly · 15 of its ownK052732 Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model…Abracair, Inc. · 2006
- Descendant · 2 generations on · 14 of its ownK161468 Transformair Indoor Air PurifierTransformair, LLC · 2017
- Descendant · 3 generations on · 11 of its ownK200500 Molekule Air Pro RXMolekule, Inc. · 2020
- Descendant · 4 generations on · 9 of its ownK202339 Molekule Air Mini, Molekule Air Mini +Molekule, Inc. · 2021
- Descendant · 4 generations on · 3 of its ownK212644 Aura StormInvictus Lighting · 2022
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K052732Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model TI 100-30PAbracair, Inc. · 2006 · cites it directly15descendants
- K161468Transformair Indoor Air PurifierTransformair, LLC · 2017 · 2 generations on14descendants
- K200500Molekule Air Pro RXMolekule, Inc. · 2020 · 3 generations on11descendants
- K202339Molekule Air Mini, Molekule Air Mini +Molekule, Inc. · 2021 · 4 generations on9descendants
- K212644Aura StormInvictus Lighting · 2022 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023830 | Airocide TI02 | Kes Science & Technology, Inc. | 2003 | — |
| 0 (this device) | K033448 | Electro-Optical Air Sterilizer with Ionizer | John Mfg., Ltd. | 2004 | — |
| +1 | K052732 | Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model TI 100-30P | Abracair, Inc. | 2006 | — |
| +2 | K161468 | Transformair Indoor Air Purifier | Transformair, LLC | 2017 | — |
| +3 | K200500 | Molekule Air Pro RX | Molekule, Inc. | 2020 | — |
| +4 | K202339 | Molekule Air Mini, Molekule Air Mini + | Molekule, Inc. | 2021 | — |
| +4 | K212644 | Aura Storm | Invictus Lighting | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 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 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? (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 | Decided |
|---|---|---|---|
| * | K023830 | Airocide TI02Summary page 2…particles from air, as class II devices, product code FRA, and it is reviewed by General Hospital Devices. 7. Predicate Device: AiroCide TiO2 (K023830) 8. Device Description Air Purifier 3707 UVC device is an adjustable and portable personal system for treatin… | 2003 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052732 | Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model TI 100-30P | 2006 | 15 |
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?
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 air purifier 3707 UVC is used to reduce airborne particles, such as: dust, smoke,
pollen, mold spores, animal hair, dust mites that may cause allergy in rooms or enclosed
areas such as treatment rooms, hospital wards, intensive care hospital wards and
residential homes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033448: Electro-Optical Air Sterilizer with Ionizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033448
Report an extraction error
Are you the manufacturer?
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