Cleared Traditional

K102454 - I-NEB AAD SYSTEM WITH TIM (FDA 510(k) Clearance)

Also includes:
I-NEB INSIGHT AAD SYSTEM

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K102454 · Respironics Respiratory Drug Delivery (Uk) , Ltd. · Anesthesiology device
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Oct 2011
Decision
424d
Days
Class 2
Risk

K102454 is an FDA 510(k) clearance for the I-NEB AAD SYSTEM WITH TIM. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Respironics Respiratory Drug Delivery (Uk) , Ltd. (Bonita Springs, US). The FDA issued a Cleared decision on October 25, 2011 after a review of 424 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Respironics Respiratory Drug Delivery (Uk) , Ltd. devices

Submission Details

510(k) Number K102454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2010
Decision Date October 25, 2011
Days to Decision 424 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
285d slower than avg
Panel avg: 139d · This submission: 424d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CAF Nebulizer (direct Patient Interface)

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