Cleared Traditional

K153748 - AirLife Misty Finity Nebulizer

K153748 is an FDA 510(k) clearance for AirLife Misty Finity Nebulizer, manufactured by Care Fusion. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 505-day FDA review.

K153748 · Care Fusion · Anesthesiology device
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May 2017
Decision
505d
Days
Class 2
Risk

K153748 is an FDA 510(k) clearance for the AirLife Misty Finity Nebulizer. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Care Fusion (Vernon Hills, US). The FDA issued a Cleared decision on May 17, 2017 after a review of 505 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 Care Fusion devices

FDA 510(k) Submission Details - K153748

510(k) Number K153748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2015
Decision Date May 17, 2017
Days to Decision 505 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
365d slower than avg
Panel avg: 140d · This submission: 505d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

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 Consultant

Vyaire Medical
Colleen O'Keeffe

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CAF Nebulizer (direct Patient Interface)

All 339
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K153748.
InnoSpire Go
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Velox Nebulizer System
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