510(k) · Cleared
ClearedI-Neb Insight Aad System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Profile Therapeutics Plc · CAF Nebulizer (Direct Patient Interface)
Cleared on Dec 9, 2005 after a 50-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Dec 9, 2005
- Review
- 50 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK052941 I-Neb Insight Aad SystemProfile Therapeutics Plc · 2005
- Descendant · cites it directly · 3 of its ownK072019 AKITA2 ApixnebActivaero America, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK142059 Fox MobileVectura GmbH · 2015
- Descendant · cites it directly · 0 of its ownK102454 I-Neb Aad System with Tim; I-Neb Insight Aad SystemRespironics Respiratory Drug Delivery (Uk), Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK090730 Akita JetActivaero America, Inc. · 2009
Most influential descendants
Showing 4 of 4 · See all- K072019AKITA2 ApixnebActivaero America, Inc. · 2007 · cites it directly3descendants
- K142059Fox MobileVectura GmbH · 2015 · 2 generations on0descendants
- K102454I-Neb Aad System with Tim; I-Neb Insight Aad SystemRespironics Respiratory Drug Delivery (Uk), Ltd. · 2011 · cites it directly0descendants
- K090730Akita JetActivaero America, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052941 | I-Neb Insight Aad System | Profile Therapeutics Plc | 2005 | — |
| +1 | K072019 | AKITA2 Apixneb | Activaero America, Inc. | 2007 | — |
| +2 | K142059 | Fox Mobile | Vectura GmbH | 2015 | — |
| +1 | K102454 | I-Neb Aad System with Tim; I-Neb Insight Aad System | Respironics Respiratory Drug Delivery (Uk), Ltd. | 2011 | — |
| +2 | K090730 | Akita Jet | Activaero America, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
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
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K072019 (Activaero America, Inc., 2007) has gone furthest, with 3 descendants of its own.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAF
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CAF
211in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAF
1in 2018
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · CAF
191in 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 intended purpose of the I-neb Insight AAD System is that is it is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medication approved for use with the I-neb AAD System for inhalation by the patient in the home care, nursing home, sub-acute institution, or hospital environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052941 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052941: I-Neb Insight Aad System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052941
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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