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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Microvapor Devices
Terrence O'Brien

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 441
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K142541.
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Besmed Reusable Jet Nebulizer
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Propeller Model 2014-D Sensor
K143671 · Reciprocal Labs · Jun 2015