510(k) · Cleared

Cleared

Transneb Compressor W/Nebulizer, Model 5000

K032170510(k) TraditionalCleared May 28, 2004317-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

Medical Industries America, Inc. · CAF Nebulizer (Direct Patient Interface)

Cleared on May 28, 2004 as substantially equivalent to K914836 (Omron Healthcare, Inc., 1992) and 2 other predicates after a 317-day review. Its family tree reaches back 1 generation to 1992. 3 later devices descend from it.

Decided: May 28, 2004
Review: 317 days
Class: Class II
Product code: CAF
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K914836 (1992). 3 ancestors in all. 3 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK914836 Omron Compressor Nebulizer- Model NE-C09Omron Healthcare, Inc. · 1992
This deviceK032170 Transneb Compressor W/Nebulizer, Model 5000Medical Industries America, Inc. · 2004
Descendant · cites it directly · 2 of its ownK042483 Invacare Pro, Compact and Portable DesktopInvacare Corporation · 2005
Descendant · 2 generations on · 0 of its ownK072163 Happyneb II, Happyneb Iii, Speedy, Nebby Plus and Myneb, Model 53A Health Care S.R.L. · 2008
Descendant · 2 generations on · 0 of its ownK062014 Families of Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, Q03…Flaem Nuova S.P.A. · 2007

Most influential descendants

Showing 3 of 3 · See all

K042483Invacare Pro, Compact and Portable DesktopInvacare Corporation · 2005 · cites it directly2descendants
K072163Happyneb II, Happyneb Iii, Speedy, Nebby Plus and Myneb, Model 53A Health Care S.R.L. · 2008 · 2 generations on0descendants
K062014Families of Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, Q03, FJ03, and Walkie-NebFlaem Nuova S.P.A. · 2007 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K914836	Omron Compressor Nebulizer- Model NE-C09	Omron Healthcare, Inc.	1992	—
0 (this device)	K032170	Transneb Compressor W/Nebulizer, Model 5000	Medical Industries America, Inc.	2004	—
+1	K042483	Invacare Pro, Compact and Portable Desktop	Invacare Corporation	2005	—
+2	K072163	Happyneb II, Happyneb Iii, Speedy, Nebby Plus and Myneb, Model 5	3A Health Care S.R.L.	2008	—
+2	K062014	Families of Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, Q03, FJ03, and…	Flaem Nuova S.P.A.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2007	1	0
2008	1	0

FIG. 1 — Lineage of K032170, 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? (3)

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
*	K914836	Omron Compressor Nebulizer- Model NE-C09 Summary page 1 …Classification Name: Nebulizer (Direct Patient Interface) Substantially Equivalent to Compressor: Omron Healthcare Inc.'s CompAir Elite K914836 Nebulizer: Pari LC Star K963924 & 56 Series Jet Nebulizer K02 1443 Device Description and Overview…	Omron Healthcare, Inc.	1992	—
*	K963924	LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70 Summary page 1 …rect Patient Interface) Substantially Equivalent to Compressor: Omron Healthcare Inc.'s CompAir Elite K914836 Nebulizer: Pari LC Star K963924 & 56 Series Jet Nebulizer K02 1443 Device Description and Overview The TransNeb system consists of a nebuli…	Pari Holding Co.	1996	—
*	K021443	56 Series Jet Nebulizer Summary page 1 …stantially Equivalent to Compressor: Omron Healthcare Inc.'s CompAir Elite K914836 Nebulizer: Pari LC Star K963924 & 56 Series Jet Nebulizer K02 1443 Device Description and Overview The TransNeb system consists of a nebulizer and a DC powered piston-type…	Project Marketing	2002	—

Also cleared against K914836: 3 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K042483	Invacare Pro, Compact and Portable Desktop	Invacare Corporation	2005	2

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 3 ancestors has a recall.
Of its descendants, K042483 (Invacare Corporation, 2005) has gone furthest, with 2 descendants of its own.
3 other devices also cite its predicate K914836.

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.

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 TransNeb compressor/nebulizer includes a DC powered air compressor that provides a source of compressed air for home health care use. The compressor is used with a venturi (pneumatic nebulizer) to convert certain inhaled drugs into an aerosol form for inhalation by a patient. The device can be used with adult or pediatric patients.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032170 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032170: Transneb Compressor W/Nebulizer, Model 5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032170

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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