# K033448: Electro-Optical Air Sterilizer with Ionizer

- Pathway: 510(k) (Traditional)
- Applicant: John Mfg., Ltd.
- Decided: Jul 12, 2004 after 257 days
- Product code: FRA (Purifier, Air, Ultraviolet, Medical)
- Device class: 2
- Regulation: 21 CFR 880.6500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K023830 (2003). 1 ancestor in all.
16 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023830: Airocide TI02, Kes Science & Technology, Inc. (2003) Summary page 2.

## Most influential descendants
- K052732: Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model TI 100-30P (2006), 15 descendants of its own
- K161468: Transformair Indoor Air Purifier (2017), 14 descendants of its own
- K200500: Molekule Air Pro RX (2020), 11 descendants of its own
- K202339: Molekule Air Mini, Molekule Air Mini + (2021), 9 descendants of its own
- K212644: Aura Storm (2022), 3 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K033448
Methodology: https://510kreport.com/methodology