510(k) · Cleared

Cleared

Nevoni Classic, Model 6600-PO

K082878510(k) AbbreviatedCleared Dec 30, 200892-day reviewClass II21 CFR 868.5630

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

Nsr Comercio E Representacoes Ltda · CAF Nebulizer (Direct Patient Interface)

Cleared on Dec 30, 2008 as substantially equivalent to K992643 (Invacare Corp., 1999) and 3 other predicates after a 92-day review. Its family tree reaches back 3 generations to 1992.

Decided: Dec 30, 2008
Review: 92 days
Class: Class II
Product code: CAF
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K922623 (1992). 14 ancestors in all, the oldest K894555 (1990). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK922623 Nebulizer SystemHealthdyne, Inc. · 1992
2 generations backK970289 Compressor/Nebulizer #3650Devilbiss Health Care, Inc. · 1997
1 generation backK020932 Devilbiss Pulmo-Aide Compact CompressorSunrise Medical · 2002
This deviceK082878 Nevoni Classic, Model 6600-PONsr Comercio E Representacoes Ltda · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K922623	Nebulizer System	Healthdyne, Inc.	1992	—
−2	K970289	Compressor/Nebulizer #3650	Devilbiss Health Care, Inc.	1997	—
−1	K020932	Devilbiss Pulmo-Aide Compact Compressor	Sunrise Medical	2002	—
0 (this device)	K082878	Nevoni Classic, Model 6600-PO	Nsr Comercio E Representacoes Ltda	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	2	0
1992	1	0
1993	1	0
1994	1	0
1995	1	0
1996	1	0
1997	1	0
1999	1	0
2000	2	0

FIG. 1 — Lineage of K082878, 1992–2008Source: 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 CAF? 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 CAF device

#1 K260270 FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)score 13.2 · 7 generations · no Class I recall
#2 Held for the reportin the report
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What was it cleared against? (4)

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
*	K992643	Model Irc 1001 Aerosol Compressor Summary page 2 …Marketed Predicate Device 510(k) Registration # Invacare Model IRC 1001 Aerosol Compressor K992643 Sunrise Medical Devilbiss Model 3655 K020932 Salter Labs Aire Compressor…	Invacare Corp.	1999	—
*	K020932	Devilbiss Pulmo-Aide Compact Compressor Summary page 2 …on # Invacare Model IRC 1001 Aerosol Compressor K992643 Sunrise Medical Devilbiss Model 3655 K020932 Salter Labs Aire Compressor K992285 Intended Use The Nevoni Classic 660…	Sunrise Medical	2002	—
*	K992285	Salter Aire Compressor Summary page 2 …643 Sunrise Medical Devilbiss Model 3655 K020932 Salter Labs Aire Compressor K992285 Intended Use The Nevoni Classic 6600-PO nebulizer is an ac powered portable compressor. This portable device uses a pne…	Salter Labs	2000	—
*	K993492	Devilbiss Nebulizer Model 800 Summary page 3 …y equivalent to: · Invacare Model IRC 1001 Aerosol Compressor FDA 51 Ok Registration# K992643 * DeVilbiss Model 800 FDA 51 Ok Registration# K993492 · Salter Labs Salter Aire Compressor FDA 51 Ok Registration# K992285 Comparative Product Table:…	Sunrise Medical Hhg, Inc.	2000	—

Also cleared against K992643: 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 16 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
None of the 14 ancestors has a recall.
2 other devices also cite its predicate K992643.

How does its category compare?

All CAF devices

CAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · CAF

7in 2025

2007high 18 (2007) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAF

211in 2025

2007high 324 (2021) · low 98 (2007)2026

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

Recalls per year · CAF

1in 2018

2007high 14 (2017) · low 0 (2008)2026

Class I (13 since 2007) Class II/III not classified

Adverse event reports per year · CAF

191in 2025

2007high 256 (2017) · low 11 (2008)2025

MAUDE reports naming product code CAF, 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	18	98	1	26
2008	12	123	0	11
2009	8	163	0	15
2010	10	114	0	37
2011	10	157	1	237
2012	9	126	0	138
2013	9	238	0	217
2014	9	151	5	123
2015	8	186	3	166
2016	5	186	1	201
2017	8	253	14 (13)	256
2018	9	161	1	162
2019	3	266	0	185
2020	6	219	0	117
2021	8	324	0	161
2022	4	176	0	55
2023	8	279	0	107
2024	4	251	0	102
2025	7	211	0	191
2026	2	—	0	—

What is it indicated for?

The Nevoni Classic 6600-PO nebulizer is an' ac powered portable compressor. This portable device uses a pneumatic piston that compresss air, forcing it to flow into the nebulizer cup. The force of the air flowing into tihe nebulizer cup disperses the medicine into fine mist particles for the inhalation~ treatment basel on a physician's prescription. This device is intended for single patient home therapy.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082878 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082878: Nevoni Classic, Model 6600-PO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082878

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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