510(k) Report

510(k) · Cleared

Cleared

Families of Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, Q03, FJ03, and Walkie-Neb

K062014510(k) TraditionalCleared Mar 22, 2007248-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

Flaem Nuova S.P.A. · CAF Nebulizer (Direct Patient Interface)

Cleared on Mar 22, 2007 as substantially equivalent to K013027 (Respironics Healthscan, Inc., 2001) and 3 other predicates after a 248-day review. Its family tree reaches back 3 generations to 1992.

Decided
Mar 22, 2007
Review
248 days
Class
Class II
Product code
CAF
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K914836 (1992). 12 ancestors in all, the oldest K914251 (1992). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor2000: 1 other ancestor1992: 2 other ancestors1998: 1 other ancestor1997: 1 other ancestor1995: 1 other ancestor2002: 1 other ancestor1996: 1 other ancestorK914836 · Omron Compressor Nebulizer- Model NE-C09 · Omron Healthcare, Inc. · 1992K032170 · Transneb Compressor W/Nebulizer, Model 5000 · Medical Industries America, Inc. · 2004K042483 · Invacare Pro, Compact and Portable Desktop · Invacare Corporation · 20051990199520002005
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 4 other ancestors3 generations back: 2 other ancestors K042483 · Invacare Pro, Compact and Portable Desktop · Invacare Corporation · 2005K032170 · Transneb Compressor W/Nebulizer, Model 5000 · Medical Industries America, Inc. · 2004K914836 · Omron Compressor Nebulizer- Model NE-C09 · Omron Healthcare, Inc. · 19920
  1. Root · 3 generations backK914836 Omron Compressor Nebulizer- Model NE-C09Omron Healthcare, Inc. · 1992
  2. 2 generations backK032170 Transneb Compressor W/Nebulizer, Model 5000Medical Industries America, Inc. · 2004
  3. 1 generation backK042483 Invacare Pro, Compact and Portable DesktopInvacare Corporation · 2005
  4. This deviceK062014 Families of Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, Q03…Flaem Nuova S.P.A. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K914836Omron Compressor Nebulizer- Model NE-C09Omron Healthcare, Inc.1992—
−2K032170Transneb Compressor W/Nebulizer, Model 5000Medical Industries America, Inc.2004—
−1K042483Invacare Pro, Compact and Portable DesktopInvacare Corporation2005—
0 (this device)K062014Families 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 clearedDevicesWith a Class I recall
199220
199510
199610
199710
199810
200010
200110
200210
FIG. 1 — Lineage of K062014, 1992–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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. #1 K260270 FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)score 13.2 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 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.

TypeNumberDeviceApplicantDecidedRecalls
*K013027Mister Neb Nebulizer Compressor, with Nebulizer, Model HS123
Summary page 1
…b, FJO3, Q03 and Walkie-Neb are substantially equivalent to a combination of the following devices: V Respironics, nebulizer compressor MISTER NEB -K013027, 1' Healthdyne Inc NEBULIZER SYSTEM - K922623, VInvacare PRO, COMPACT e PORTABLE DESKTOP Nebulizer -…
Respironics Healthscan, Inc.2001—
*K922623Nebulizer System
Summary page 1
…valent to a combination of the following devices: V Respironics, nebulizer compressor MISTER NEB -K013027, 1' Healthdyne Inc NEBULIZER SYSTEM - K922623, VInvacare PRO, COMPACT e PORTABLE DESKTOP Nebulizer - K042483, and VSalter Labs SALTER AIRE…
Healthdyne, Inc.1992—
*K042483Invacare Pro, Compact and Portable Desktop
Summary page 1
…er compressor MISTER NEB -K013027, 1' Healthdyne Inc NEBULIZER SYSTEM - K922623, VInvacare PRO, COMPACT e PORTABLE DESKTOP Nebulizer - K042483, and VSalter Labs SALTER AIRE COMPRESSOR -K992285.…
Invacare Corporation2005—
*K992285Salter Aire Compressor
Summary page 1
…NEBULIZER SYSTEM - K922623, VInvacare PRO, COMPACT e PORTABLE DESKTOP Nebulizer - K042483, and VSalter Labs SALTER AIRE COMPRESSOR -K992285. 000010 4. Device Descr…
Salter Labs2000—

Also cleared against K013027: 1 other device →

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 15 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
  • None of the 12 ancestors has a recall.
  • 1 other device also cites its predicate K013027.

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. 2007, this device’s year, is highlighted.

FDA decisions per year · CAF

7in 2025

2007: 182008: 122009: 82010: 102011: 102012: 92013: 92014: 92015: 82016: 52017: 82018: 92019: 32020: 62021: 82022: 42023: 82024: 42025: 72026 (partial year): 2
2007high 18 (2007) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAF

211in 2025

2007: 98 days median2008: 123 days median2009: 163 days median2010: 114 days median2011: 157 days median2012: 126 days median2013: 238 days median2014: 151 days median2015: 186 days median2016: 186 days median2017: 253 days median2018: 161 days median2019: 266 days median2020: 219 days median2021: 324 days median2022: 176 days median2023: 279 days median2024: 251 days median2025: 211 days median
2007high 324 (2021) · low 98 (2007)2026

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

Recalls per year · CAF

1in 2018

2007: 12011: 12014: 52015: 32016: 12017: 14, 13 Class I2018: 1
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

2007: 262008: 112009: 152010: 372011: 2372012: 1382013: 2172014: 1232015: 1662016: 2012017: 2562018: 1622019: 1852020: 1172021: 1612022: 552023: 1072024: 1022025: 191
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071898126
200812123011
20098163015
201010114037
2011101571237
201291260138
201392380217
201491515123
201581863166
201651861201
2017825314 (13)256
201891611162
201932660185
202062190117
202183240161
20224176055
202382790107
202442510102
202572110191
20262—0—

What is it indicated for?

The nebulizer compressors Master Neb, Primo Neb, SCO3, Neb Aid, 4.2.Neb, FJO3, and Q03 are intended to provide a source of compressed air for medical purposes, to be used in home health care and hospital use. The Walkie-Neb model is intended to be used only in home health care.

These devices are indicated for use with all commercially available small volume pneumatic nebulizers, to produce a fine aerosol mist of medication for respiratory therapy, for both adult and pediatric patients who have been prescribed inhalation therapy or medication.

Indications for use as stated in the FDA summary.

Also cleared against K013027

1 other device cites the same predicate.

  • K031908MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer, and MED2000 Spa Nebulizer, Model A1/C…Med2000 S.R.L. · 2004

More from Flaem Nuova S.P.A.

2 FDA decisions under this applicant name. See the company

  • K062484Flaem Nuova RF6 Basic and RF6 Plus NebulizersFlaem Nuova S.P.A. · 2007

Recent decisions in CAF

The CAF category page

  • K254171Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)Shenzhen Mericonn Technology Co., Ltd. · 2026
  • K260270FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o. · 2026
  • K251572eRapid with eTrack SystemPari Respiratory Equipment, Inc. · 2025
  • K251659Mesh Nebulizer (H6)Qingdao Future Medical Technology Co., Ltd. · 2025
  • K244035Portable mesh nebulizer (JM821)Shenzhen Jermei Medical Device Technology Co., Ltd. · 2025

https://510kreport.com/device/K062014 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062014: Families of Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, Q03, FJ03, and Walkie-Neb.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062014

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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