510(k) · Cleared
ClearedI-Neb 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 Sep 23, 2005 as substantially equivalent to K030747 (Profile Therapeutics Plc, 2004) and 2 other predicates after a 326-day review. Its family tree reaches back 4 generations to 1994. 1 of the 15 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.
- Decided
- Sep 23, 2005
- Review
- 326 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K933535 (1994). 8 ancestors in all, the oldest K923024 (1992). 6 later devices descend from it, 2 citing it directly. 1 of the 15 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 deviceK042991 I-Neb Aad SystemProfile Therapeutics Plc · 2005
- Descendant · cites it directly · 4 of its ownK100380 Altera Nebulizer System, Model 678G1002Pari Respiratory Equipment, Inc. · 2010
- Descendant · 2 generations on · 3 of its ownK112859 Erapid Nebulizer SystemPari Respiratory Equipment, Inc. · 2012
- Descendant · 3 generations on · 1 of its ownK223840 eRapid Nebulizer SystemPari Respiratory Equipment, Inc. · 2023
- Descendant · 4 generations on · 0 of its ownK251572 eRapid with eTrack SystemPari Respiratory Equipment, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK162785 Velox Nebulizer SystemPari Respiratory Equipment, Inc. · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K990801 Minimed 508 Insulin Pump2 generations back · 1999
Most influential descendants
Showing 5 of 6 · See all- K100380Altera Nebulizer System, Model 678G1002Pari Respiratory Equipment, Inc. · 2010 · cites it directly4descendants
- K112859Erapid Nebulizer SystemPari Respiratory Equipment, Inc. · 2012 · 2 generations on3descendants
- K223840eRapid Nebulizer SystemPari Respiratory Equipment, Inc. · 2023 · 3 generations on1descendant
- K251572eRapid with eTrack SystemPari Respiratory Equipment, Inc. · 2025 · 4 generations on0descendants
- K162785Velox Nebulizer SystemPari Respiratory Equipment, Inc. · 2017 · 3 generations on0descendants
View 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) | K042991 | I-Neb Aad System | Profile Therapeutics Plc | 2005 | — |
| +1 | K100380 | Altera Nebulizer System, Model 678G1002 | Pari Respiratory Equipment, Inc. | 2010 | — |
| +2 | K112859 | Erapid Nebulizer System | Pari Respiratory Equipment, Inc. | 2012 | — |
| +3 | K223840 | eRapid Nebulizer System | Pari Respiratory Equipment, Inc. | 2023 | — |
| +4 | K251572 | eRapid with eTrack System | Pari Respiratory Equipment, Inc. | 2025 | — |
| +3 | K162785 | Velox Nebulizer System | Pari Respiratory Equipment, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (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 | Decided |
|---|---|---|---|
| * | K030747 | Prodose Aad SystemSummary page 1…vices 1010 Murry Ridge Lane Murrysville, PA 15668-8525 Predicate Devices Prodose AAD System, K030747 Halolite AAD System K991685 NeUO4 K923024 [Device Description Th… | 2004 |
| * | K991685 | Halolite Aad System with Dedicated CompressorSummary page 1…Murrysville, PA 15668-8525 Predicate Devices Prodose AAD System, K030747 Halolite AAD System K991685 NeUO4 K923024 [Device Description The I-neb AAD system is a portable, single patient use, reusa… | 1999 |
| * | K923024 | NE-U04/NE U04FSummary page 1…PA 15668-8525 Predicate Devices Prodose AAD System, K030747 Halolite AAD System K991685 NeUO4 K923024 [Device Description The I-neb AAD system is a portable, single patient use, reusable, ultrasonic (vibrating mesh) nebulizer s… | 1992 |
What descends from it? (6)
2 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 11 years and passes through 2 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K100380 (Pari Respiratory Equipment, Inc., 2010) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K030747.
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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K042991 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042991: I-Neb 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/K042991
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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