Cleared Traditional

K002862 - PRONEB ULTRA MODEL NUMBER 85B0100

K002862 is an FDA 510(k) clearance for PRONEB ULTRA MODEL NUMBER 85B0100, manufactured by Pari Holding Co.. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Traditional 510(k) pathway after a 181-day FDA review.

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

FDA 510(k) Submission Details - K002862

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
41d slower than avg
Panel avg: 140d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTI Device Classification - Class 2, Special Controls

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.

Regulatory Peers - BTI Compressor, Air, Portable

All 31
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K002862.
VENTILAIR II MEDICAL AIR COMPRESSOR
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AEROMIST LT, MODEL HCS15004
K031686 · Medline Industries, Inc. · Jan 2004
COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E
K023354 · Siemens Elema AB · Sep 2003
MEDICAL AIR COMPRESSOR, MODEL # 8413419
K982789 · Drager, Inc. · Oct 1998
DEVILBISS 8650D
K963349 · Devilbiss Health Care, Inc. · Jun 1997
503 MAXI COMPRESSOR
K940630 · Medical Industries America, Inc. · Feb 1995