Cleared Traditional

K002862 - PRONEB ULTRA MODEL NUMBER 85B0100 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K002862 · Pari Holding Co. · Anesthesiology device
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Mar 2001
Decision
181d
Days
Class 2
Risk

K002862 is an FDA 510(k) clearance for the PRONEB ULTRA MODEL NUMBER 85B0100. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Pari Holding Co. (Midlothian, US). The FDA issued a Cleared decision on March 13, 2001 after a review of 181 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6250 - 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 Pari Holding Co. devices

Submission Details

510(k) Number K002862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2000
Decision Date March 13, 2001
Days to Decision 181 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 139d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTI Compressor, Air, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.6250
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.