Cleared Traditional

K002468 - SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050

K002468 is an FDA 510(k) clearance for SAN UP S.A. NEBULIZER COMPRESSOR, manufactured by San UP S.A.. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K002468 · San UP S.A. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
203d
Days
Class 2
Risk

K002468 is an FDA 510(k) clearance for the SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by San UP S.A. (Great Neck, US). The FDA issued a Cleared decision on March 2, 2001 after a review of 203 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.

FDA 510(k) Submission Details - K002468

510(k) Number K002468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2000
Decision Date March 02, 2001
Days to Decision 203 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 140d · This submission: 203d
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 71
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K002468.
PULMO-MIST COMPRESSOR MODEL # 4323
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PRONEB ULTRA MODEL NUMBER 85B0100
K002862 · Pari Holding Co. · Mar 2001
MEDICAL AIR COMPRESSOR, MODEL # 8413419
K982789 · Drager, Inc. · Oct 1998
DEVILBISS 8650D
K963349 · Devilbiss Health Care, Inc. · Jun 1997
ALRECO 40400
K951926 · Allan Rehnstrom AB · Dec 1995
K002468 · SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050
Download PDF FDA Summary San UP S.A.