Cleared Abbreviated

K142541 - POCKET NEB

K142541 is an FDA 510(k) clearance for POCKET NEB, manufactured by Microvaper Devices. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Abbreviated 510(k) pathway after a 499-day FDA review.

K142541 · Microvaper Devices · Anesthesiology device
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Jan 2016
Decision
499d
Days
Class 2
Risk

K142541 is an FDA 510(k) clearance for the POCKET NEB. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Microvaper Devices (Winter Park, US). The FDA issued a Cleared decision on January 22, 2016 after a review of 499 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. 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 Microvaper Devices devices

FDA 510(k) Submission Details - K142541

510(k) Number K142541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2014
Decision Date January 22, 2016
Days to Decision 499 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
359d slower than avg
Panel avg: 140d · This submission: 499d
Pathway characteristics
Standards-based clearance path.

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 Peers - CAF Nebulizer (direct Patient Interface)

All 224
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K142541.
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K153010 · Teleflexmedical, Inc. · Jul 2016
HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML
K142153 · Teleflexmedical, Inc. · Apr 2015
AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS
K141214 · Teleflexmedical, Inc. · Dec 2014
COMP A-I-R
K141140 · Omron Healthcare, Inc. · Sep 2014