510(k) · Cleared

Cleared

Qorda QD1

K220990510(k) TraditionalCleared Sep 14, 2022163-day reviewClass II21 CFR 880.5045

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

Winix, Inc. · FRF Cleaner, Air, Medical Recirculating

Cleared on Sep 14, 2022 as substantially equivalent to K200321 (Novaerus Us, Inc., 2020) after a 163-day review. Its family tree reaches back 3 generations to 1997.

Decided: Sep 14, 2022
Review: 163 days
Class: Class II
Product code: FRF
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K972064 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK972064 Microcon 800MUV, Microcon 400MUV, Microcon Exc-BuvBiological Controls, Inc. · 1997
2 generations backK070722 Plasmair, Model T2006Airinspace B.V. · 2007
1 generation backK200321 Novaerus NV1050Novaerus Us, Inc. · 2020
This deviceK220990 Qorda QD1Winix, Inc. · 2022

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K972064	Microcon 800MUV, Microcon 400MUV, Microcon Exc-Buv	Biological Controls, Inc.	1997	—
−2	K070722	Plasmair, Model T2006	Airinspace B.V.	2007	—
−1	K200321	Novaerus NV1050	Novaerus Us, Inc.	2020	—
0 (this device)	K220990	Qorda QD1	Winix, Inc.	2022	—

FIG. 1 — Lineage of K220990, 1997–2022Source: 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 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

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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	Applicant	Decided	Recalls
*	K200321	Novaerus NV1050 Summary page 4 …m  Product Code: FRF  Panel: General Hospital  Regulation Number: 21 CFR 880.5045  Device Class: Class II  Date prepared: 08/22/2022 Primary Predicate Device - K200321, Novaerus NV1050 manufactured by Novaerus US Inc. Indications for use The Qorda QD1 is intended as a room recirculating air clea…	Novaerus Us, Inc.	2020	—

Also cleared against K200321: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 10.0 years on median.
None of the 3 ancestors has a recall.
2 other devices also cite its predicate K200321.

How does its category compare?

All FRF devices

FRF Cleaner, Air, Medical Recirculating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · FRF

1in 2025

2007high 3 (2022) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRF

163in 2022

2007high 163 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRF

1in 2012

2007high 1 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FRF

3in 2013

2007high 3 (2008) · low 0 (2009)2025

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 Qorda QD1 is intended as a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles from the air for medical purposes.

The Qorda QD1 has been demonstrated to remove the following organisms under the following exposure conditions:

MS2 bacteriophage: Turbo MODE, 5.6 log reduction, 20 minutes; Sleep MODE, 4.9 log reduction, 45 minutes.

Bacillus subtilis endospores: Turbo MODE, 4.4 log reduction, 20 minutes; Sleep MODE, 4.3 log reduction, 60 minutes.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K220990 · printed Nov 6, 2026

Cite this page

510(k) Report. “K220990: Qorda QD1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220990

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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