510(k) · Cleared

Cleared

Odorox (R) Idu/RX (TM) in-Duct Models, Odorox (R) Idu/RX (TM) Mobile Disinfection Units, Odorox (R) Slimline/RX (TM) Slimli

K133800510(k) TraditionalCleared Dec 19, 2014371-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

Hgi Industires · FRA Purifier, Air, Ultraviolet, Medical

Cleared on Dec 19, 2014 as substantially equivalent to K062716 (Eco-Rx, Inc., 2006) and 1 other predicate after a 371-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.

Decided: Dec 19, 2014
Review: 371 days
Class: Class II
Product code: FRA
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K951981 (1995). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK951981 RXAIR 3000Clean Air Research & Development · 1995
This deviceK133800 Odorox (R) Idu/RX (TM) in-Duct Models, Odorox (R) Idu/RX (TM) Mobile…Hgi Industires · 2014
Descendant · cites it directly · 0 of its ownK252128 Zener® (model ZEN-001-B1)Uvx, Inc. · 2025

Most influential descendants

Showing 1 of 1 · See all

K252128Zener® (model ZEN-001-B1)Uvx, Inc. · 2025 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K951981	RXAIR 3000	Clean Air Research & Development	1995	—
0 (this device)	K133800	Odorox (R) Idu/RX (TM) in-Duct Models, Odorox (R) Idu/RX (TM) Mobile…	Hgi Industires	2014	—
+1	K252128	Zener® (model ZEN-001-B1)	Uvx, Inc.	2025	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2025	1	0

FIG. 1 — Lineage of K133800, 1995–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K062716	Eco-RX Air Purifier with UV Light, Model RX-400 Summary page 6 …lowing FDA approved, legally marketed systems:  ECO-Rx AIR PURIFIER WITH UV LIGHT MODEL RX-400 o 510(k) Number: K062716 o Regulation Number: 21 CFR 880.6500 o Regulation Name: Medical Ultravi…	Eco-Rx, Inc.	2006	—
*	K951981	RXAIR 3000 Summary page 6 …e: Traditional o Combination Product: No  RXAir 3000 o 510(k) Number: K951981 o Regulation Number: 21 CRF 880-6500 o Regulation Name: Medical Ultravi…	Clean Air Research & Development	1995	—

Also cleared against K062716: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K252128	Zener® (model ZEN-001-B1)	Uvx, Inc.	2025	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?

None of the 2 ancestors has a recall.
Of its descendants, K252128 (Uvx, Inc., 2025) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K062716.

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. 2014, this device’s year, is highlighted.

FDA decisions per year · FRA

1in 2025

2007high 5 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRA

205in 2024

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

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

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	1	—	0
2015	0	—	1
2016	0	—	0
2017	1	—	0
2018	0	—	0
2019	0	—	0
2020	2	—	0
2021	5	190	1
2022	4	175	1
2023	2	—	0
2024	4	205	2
2025	1	—	0
2026	0	—	—

What is it indicated for?

The MDU/Rx™ medical model is an ultraviolet (UV) air purifying device intended for the

reduction of bacteria and the MS2 and Phi-X174 virus in air in medical facilities. The

MDU/Rx™ medical device is non sterile.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K133800 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133800: Odorox (R) Idu/RX (TM) in-Duct Models, Odorox (R) Idu/RX (TM) Mobile Disinfection Units, Odorox (R) Slimline/RX (TM) Slimli.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133800

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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