510(k) · Cleared
ClearedI-Neb Aad System with Tim; I-Neb Insight Aad System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics Respiratory Drug Delivery (Uk), Ltd. · CAF Nebulizer (Direct Patient Interface)
Cleared on Oct 25, 2011 as substantially equivalent to K062263 (Omron Healthcare, Inc., 2007) and 4 other predicates after a 424-day review. Its family tree reaches back 5 generations to 1994. 1 of the 19 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 25, 2011
- Review
- 424 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K933535 (1994). 18 ancestors in all, the oldest K870027 (1987). No later device cites it as a predicate yet. 1 of the 19 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK933535 Ventstream Drug NebulizerMedic-Aid, Ltd. · 1994
- 4 generations backK981772 Halolite Aad SystemMedic-Aid, Ltd. · 1998
- 3 generations backK991685 Halolite Aad System with Dedicated CompressorMedic-Aid, Ltd. · 1999
- 2 generations backK030747 Prodose Aad SystemProfile Therapeutics Plc · 2004
- 1 generation backK042991 I-Neb Aad SystemProfile Therapeutics Plc · 2005
- This deviceK102454 I-Neb Aad System with Tim; I-Neb Insight Aad SystemRespironics Respiratory Drug Delivery (Uk), Ltd. · 2011
Class I recalls in this family
- K990801 Minimed 508 Insulin Pump3 generations back · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933535 | Ventstream Drug Nebulizer | Medic-Aid, Ltd. | 1994 | — |
| −4 | K981772 | Halolite Aad System | Medic-Aid, Ltd. | 1998 | — |
| −3 | K991685 | Halolite Aad System with Dedicated Compressor | Medic-Aid, Ltd. | 1999 | — |
| −2 | K030747 | Prodose Aad System | Profile Therapeutics Plc | 2004 | — |
| −1 | K042991 | I-Neb Aad System | Profile Therapeutics Plc | 2005 | — |
| 0 (this device) | K102454 | I-Neb Aad System with Tim; I-Neb Insight Aad System | Respironics Respiratory Drug Delivery (Uk), Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 1 |
| 2000 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K062263 | Omron Micro-Air Vibrating Mesh Nebulizer, Model NE-U22Summary page 1…ct patient interface) Classification Name: Nebulizer CAF - 868.5630 Predicate Devices: K062263 - Omron U-22 K870027 - Salter 8900 nebulzier K0… | 2007 |
| * | K870027 | Hand Held Pheumatic Powered (Disposable) NebulizerSummary page 1…Nebulizer CAF - 868.5630 Predicate Devices: K062263 - Omron U-22 K870027 - Salter 8900 nebulzier K072019 - Activaero - AKITA' APIXNEB… | 1987 |
| * | K072019 | AKITA2 ApixnebSummary page 1…ate Devices: K062263 - Omron U-22 K870027 - Salter 8900 nebulzier K072019 - Activaero - AKITA' APIXNEB K042991 - Profile - I-neb AAD… | 2007 |
| * | K042991 | I-Neb Aad SystemSummary page 1…K870027 - Salter 8900 nebulzier K072019 - Activaero - AKITA' APIXNEB K042991 - Profile - I-neb AAD K052491 - Profile - 1-neb Insight Device Description: The I-neb A… | 2005 |
| * | K052941 | I-Neb Insight Aad System Our reading of the summary gave K052491, FDA’s number for Axya Model 6500 Axyaloop Self-Tapping Bone Anchor (Axya Medical, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “I-neb Insight AAD System”. | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 3 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 3 of the 18 ancestors have a recall of any class; 1 has a Class I recall.
- 11 other devices also cite its predicate K062263.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 I-neb AAD system with TIM is a nebulizer system designed to aerosolize liquid medication for inhalation by the patient in the home care, nursing home, sub-acute institution, or hospital environment.
The I-neb Insight AAD System is monitoring software that provides feedback to the patient recording treatment events, including treatment times and compliance data which is also available to the clinician. It is an accessory to ain accessory for use with the I-neb AAD system.
The I-neb AAD system with TIM 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/K102454 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102454: I-Neb Aad System with Tim; I-Neb Insight Aad System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102454
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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