510(k) · Cleared
ClearedAKITA2 Apixneb
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Activaero America, Inc. · CAF Nebulizer (Direct Patient Interface)
Cleared on Nov 5, 2007 as substantially equivalent to K052941 (Profile Therapeutics Plc, 2005) and 3 other predicates after a 105-day review. Its family tree reaches back 4 generations to 1994. 1 of the 17 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Nov 5, 2007
- Review
- 105 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K933535 (1994). 13 ancestors in all. 3 later devices descend from it, 3 citing it directly. 1 of the 17 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK933535 Ventstream Drug NebulizerMedic-Aid, Ltd. · 1994
- 3 generations backK981772 Halolite Aad SystemMedic-Aid, Ltd. · 1998
- 2 generations backK991685 Halolite Aad System with Dedicated CompressorMedic-Aid, Ltd. · 1999
- 1 generation backK030747 Prodose Aad SystemProfile Therapeutics Plc · 2004
- This deviceK072019 AKITA2 ApixnebActivaero America, Inc. · 2007
- Descendant · cites it directly · 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 · cites it directly · 0 of its ownK090730 Akita JetActivaero America, Inc. · 2009
Class I recalls in this family
- K990801 Minimed 508 Insulin Pump2 generations back · 1999
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933535 | Ventstream Drug Nebulizer | Medic-Aid, Ltd. | 1994 | — |
| −3 | K981772 | Halolite Aad System | Medic-Aid, Ltd. | 1998 | — |
| −2 | K991685 | Halolite Aad System with Dedicated Compressor | Medic-Aid, Ltd. | 1999 | — |
| −1 | K030747 | Prodose Aad System | Profile Therapeutics Plc | 2004 | — |
| 0 (this device) | K072019 | AKITA2 Apixneb | Activaero America, Inc. | 2007 | — |
| +1 | 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 | — |
| +1 | K090730 | Akita Jet | Activaero America, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 1 |
| 2000 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
1 device in this family has a Class I recall. 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? (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 | Decided |
|---|---|---|---|
| * | K052941 | I-Neb Insight Aad SystemSummary page 1…Nebulizer (Direct Patient Interface) CAF - 868.5630 Predicate Devices: I-rieb Insight -K052941 - Profile / Respironics ProDose - K030747 - Profile!/ Respironics… | 2005 |
| * | K030747 | Prodose Aad SystemSummary page 1…CAF - 868.5630 Predicate Devices: I-rieb Insight -K052941 - Profile / Respironics ProDose - K030747 - Profile!/ Respironics eFlIowTM - K033833 - Pari… | 2004 |
| * | K033833 | Eflow Electronic Inhaler/NebulizerSummary page 1…t -K052941 - Profile / Respironics ProDose - K030747 - Profile!/ Respironics eFlIowTM - K033833 - Pari AutoNeb -- K93 5693 - Vortran Device Description The AKITA 2 APfXNEB nebulizer a… | 2004 |
| * | K935693 | Autoneb Breath Actuated Controller and Accessory KitSummary page 1…ProDose - K030747 - Profile!/ Respironics eFlIowTM - K033833 - Pari AutoNeb -- K93 5693 - Vortran Device Description The AKITA 2 APfXNEB nebulizer and the handset together constitute a single patient, multi-use, elec… | 1994 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K990801Minimed 508 Insulin PumpMedtronic Minimed · 1999 · 2 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 13 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K142059 (Vectura GmbH, 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K052941.
How does its category compare?
All CAF devicesCAF 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
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 AKITA 2 APIXNEB is a nebulizer system that will be used with patients for whom doctors have prescribed medication for nebulization in tile home care, nursing home, sub-acute institution, or hospital environment.
The AKITA 2 APIXNEB is intended for patients 3 years and older who can coordinate breathing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072019 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072019: AKITA2 Apixneb.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072019
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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