Cleared Traditional

K951259 - ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AND PU 12300

K951259 is an FDA 510(k) clearance for ICEL ULTRASONIC NEBULIZER MODELS PU 120..., manufactured by Impulso Trading Co.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K951259 · Impulso Trading Co. · Anesthesiology device
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Jun 1995
Decision
91d
Days
Class 2
Risk

K951259 is an FDA 510(k) clearance for the ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AND PU 12300. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Impulso Trading Co. (Great Neck,, US). The FDA issued a Cleared decision on June 20, 1995 after a review of 91 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Impulso Trading Co. devices

FDA 510(k) Submission Details - K951259

510(k) Number K951259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1995
Decision Date June 20, 1995
Days to Decision 91 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
49d faster than avg
Panel avg: 140d · This submission: 91d
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 408
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