# K102454: I-Neb Aad System with Tim; I-Neb Insight Aad System

- Pathway: 510(k) (Traditional)
- Applicant: Respironics Respiratory Drug Delivery (Uk), Ltd.
- Decided: Oct 25, 2011 after 424 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K933535 (1994). 18 ancestors in all.
No later device cites it as a predicate yet.
1 of 19 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062263: Omron Micro-Air Vibrating Mesh Nebulizer, Model NE-U22, Omron Healthcare, Inc. (2007) Summary page 1.
- K870027: Hand Held Pheumatic Powered (Disposable) Nebulizer, Salter Labs (1987) Summary page 1.
- K072019: AKITA2 Apixneb, Activaero America, Inc. (2007) Summary page 1.
- K042991: I-Neb Aad System, Profile Therapeutics Plc (2005) Summary page 1.
- K052941: I-Neb Insight Aad System, Profile Therapeutics Plc (2005). 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”. Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K102454
Methodology: https://510kreport.com/methodology