Cleared Traditional

K060842 - REVJET TURBO

K060842 is an FDA 510(k) clearance for REVJET TURBO, manufactured by Promedic, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K060842 · Promedic, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Jun 2006
Decision
85d
Days
Class 2
Risk

K060842 is an FDA 510(k) clearance for the REVJET TURBO. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Promedic, Inc. (Mccordsville, US). The FDA issued a Cleared decision on June 21, 2006 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Promedic, Inc. devices

FDA 510(k) Submission Details - K060842

510(k) Number K060842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2006
Decision Date June 21, 2006
Days to Decision 85 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
55d faster than avg
Panel avg: 140d · This submission: 85d
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 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 K060842.
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OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30
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SCHUCO MIST AND SCHUCO DELUXE MIST
K051260 · Allied Healthcare Products, Inc. · Sep 2005
COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321
K051365 · K-Jump Health Co., Ltd. · Jul 2005