510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Aeroneb Professional Nebulizer System, Model#AG-AP6000

K021175510(k) TraditionalCleared May 15, 200233-day reviewClass II21 CFR 868.5630Recalls 4

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

Aerogen, Inc. · CAF Nebulizer (Direct Patient Interface)

Cleared on May 15, 2002 as substantially equivalent to K970010 (Fluid Propulsion Technologies, Inc., 1997) and 2 other predicates after a 33-day review. Its family tree reaches back 1 generation to 1996. It has been recalled 4 times.

Decided
May 15, 2002
Review
33 days
Class
Class II
Product code
CAF
Recalls
4
Predicates
3

Its longest line of descent runs back 1 generation to K960854 (1996). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestor1997: 1 other ancestorK960854 · Siemens Servo Ultra Nebulizer 345 · Pacesetter, Inc. · 199619961998200020022004
Other ancestors, by generation 1 generation back: 2 other ancestors K960854 · Siemens Servo Ultra Nebulizer 345 · Pacesetter, Inc. · 19960
  1. Root · 1 generation backK960854 Siemens Servo Ultra Nebulizer 345Pacesetter, Inc. · 1996
  2. This deviceK021175 Aeroneb Professional Nebulizer System, Model#AG-AP6000Aerogen, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K960854Siemens Servo Ultra Nebulizer 345Pacesetter, Inc.1996—
0 (this device)K021175Aeroneb Professional Nebulizer System, Model#AG-AP6000Aerogen, Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200010
FIG. 1 — Lineage of K021175, 1996–2002Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K970010FPT Nebulizer
Summary page 1
…sification name: Nebulizer, 21 CFR §868.5630 (3) Identification of predicate device: Manufacturer Device 510(k) Number Aerogen Inc. Aeroneb® Portable Nebulizer System K970010/ K003022 Siemens-Elena AB Siemens Servo Ultra Nebulizer (SUN), Models 354 and 145 K960854 (4) Description of the device: The…
Fluid Propulsion Technologies, Inc.1997—
*K003022Aeroneb Portable Nebulizer
Summary page 1
…n name: Nebulizer, 21 CFR §868.5630 (3) Identification of predicate device: Manufacturer Device 510(k) Number Aerogen Inc. Aeroneb® Portable Nebulizer System K970010/ K003022 Siemens-Elena AB Siemens Servo Ultra Nebulizer (SUN), Models 354 and 145 K960854 (4) Description of the device: The Aeroneb®…
Aerogen, Inc.2000—
*K960854Siemens Servo Ultra Nebulizer 345
Summary page 1
…acturer Device 510(k) Number Aerogen Inc. Aeroneb® Portable Nebulizer System K970010/ K003022 Siemens-Elena AB Siemens Servo Ultra Nebulizer (SUN), Models 354 and 145 K960854 (4) Description of the device: The Aeroneb® Professional Nebulizer System is a multiple patient reusable pulmonary drug deliver…
Pacesetter, Inc.1996—

Also cleared against K970010: 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)

Recalls of this device

DateClassRecallRoot causeReason
Sep 2, 2014Class IIZ-0118-2015Nonconforming Material/ComponentAerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had…
Sep 2, 2014Class IIZ-0119-2015Nonconforming Material/ComponentAerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had…
Sep 2, 2014Class IIZ-0121-2015Nonconforming Material/ComponentAerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had…
Sep 2, 2014Class IIZ-0120-2015Nonconforming Material/ComponentAerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 3 ancestors has a recall.
  • 2 other devices also cite its predicate K970010.

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

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 Aeroneb® Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb® Professional Nebulizer System is suitable for use in adult and pediatric patients as described in the Instruction Manual.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K970010

2 other devices cite the same predicate.

  • K032849Aeroneb GO Nebulizer, Model AG-AG2000Aerogen, Inc. · 20031 recall
  • K992831Aeroneb II, Model Apn 200Aerogen, Inc. · 2000

More from Aerogen, Inc.

4 FDA decisions under this applicant name. See the company

  • K032849Aeroneb GO Nebulizer, Model AG-AG2000Aerogen, Inc. · 20031 recall
  • K003022Aeroneb Portable NebulizerAerogen, Inc. · 2000
  • K992831Aeroneb II, Model Apn 200Aerogen, Inc. · 2000

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/K021175 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021175: Aeroneb Professional Nebulizer System, Model#AG-AP6000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021175

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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