510(k) Report

510(k) · Cleared

Cleared

Airocide TI02

K023830510(k) TraditionalCleared Feb 4, 200378-day reviewClass II21 CFR 880.6500

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

Kes Science & Technology, Inc. · FRA Purifier, Air, Ultraviolet, Medical

Cleared on Feb 4, 2003 after a 78-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 17 later devices descend from it.

Decided
Feb 4, 2003
Review
78 days
Class
Class II
Product code
FRA
Recalls
None
Predicates
0

17 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2004: 1 descendant cleared2017: 1 descendant cleared2020: 1 descendant cleared2021: 4 descendants cleared2024: 4 descendants cleared2022: 3 descendants cleared2023: 2 descendants cleared200020052010201520202025
  1. This deviceK023830 Airocide TI02Kes Science & Technology, Inc. · 2003
  2. Descendant · cites it directly · 16 of its ownK033448 Electro-Optical Air Sterilizer with IonizerJohn Mfg., Ltd. · 2004
  3. Descendant · cites it directly · 15 of its ownK052732 Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model…Abracair, Inc. · 2006
  4. Descendant · 2 generations on · 14 of its ownK161468 Transformair Indoor Air PurifierTransformair, LLC · 2017
  5. Descendant · 3 generations on · 11 of its ownK200500 Molekule Air Pro RXMolekule, Inc. · 2020
  6. Descendant · 4 generations on · 9 of its ownK202339 Molekule Air Mini, Molekule Air Mini +Molekule, Inc. · 2021

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2004: 12006: 12017: 12020: 12021: 42022: 32023: 22024: 4
2004high 4 (2021) · low 0 (2005)2026

Most influential descendants

Showing 5 of 17 · See all
  • K033448Electro-Optical Air Sterilizer with IonizerJohn Mfg., Ltd. · 2004 · cites it directly16descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K023830Airocide TI02Kes Science & Technology, Inc.2003—
+1K033448Electro-Optical Air Sterilizer with IonizerJohn Mfg., Ltd.2004—
+1K052732Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model TI 100-30PAbracair, Inc.2006—
+2K161468Transformair Indoor Air PurifierTransformair, LLC2017—
+3K200500Molekule Air Pro RXMolekule, Inc.2020—
+4K202339Molekule Air Mini, Molekule Air Mini +Molekule, Inc.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200610
201710
202010
202140
202230
202320
202440
FIG. 1 — Lineage of K023830, 2003–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 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. #1 K212644 Aura Stormscore 13.9 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (17)

See all 17

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K033448Electro-Optical Air Sterilizer with IonizerJohn Mfg., Ltd.200416
K052732Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model TI 100-30PAbracair, Inc.200615

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, K033448 (John Mfg., Ltd., 2004) has gone furthest, with 16 descendants of its own.

How does its category compare?

All FRA devices

FRA Purifier, Air, Ultraviolet, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRA

1in 2025

2014: 12017: 12020: 22021: 52022: 42023: 22024: 42025: 1
2007high 5 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRA

205in 2024

2021: 190 days median2022: 175 days median2024: 205 days median
2007high 205 (2024) · low 175 (2022)2026

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

2015: 12021: 12022: 12024: 2
2007high 2 (2024) · low 0 (2007)2025

MAUDE reports naming product code FRA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20141—00
20150—01
20160—00
20171—00
20180—00
20190—00
20202—00
2021519001
2022417501
20232—00
2024420502
20251—00
20260—0—

What is it indicated for?

AiroCide Ti02 INTENDED USE: Potential applications include removing and mineralizing airborne contaminations of pathogens and/or harmful molds and volatile organic compounds present in rooms or enclosed areas: treatment rooms, hospital wards, intensive care hospital wards, hulding areas in jails, operating rooms, homeless shelters, pediatric waiting areas, command and control vehicles, embalming rooms in funeral homes, postal facilities. etc

Indications for use as stated in the FDA 510(k) statement.

Cite this page

510(k) Report. “K023830: Airocide TI02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023830

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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