Cleared Traditional

K091272 - BESMED JET NEBULIZER BOTTLE SET

K091272 is an FDA 510(k) clearance for BESMED JET NEBULIZER BOTTLE SET, manufactured by Besmed Health Business Corp. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K091272 · Besmed Health Business Corp · Anesthesiology device
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Nov 2009
Decision
194d
Days
Class 2
Risk

K091272 is an FDA 510(k) clearance for the BESMED JET NEBULIZER BOTTLE SET. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Besmed Health Business Corp (Hsin Chu City, TW). The FDA issued a Cleared decision on November 10, 2009 after a review of 194 days - an extended review 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: 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 Besmed Health Business Corp devices

FDA 510(k) Submission Details - K091272

510(k) Number K091272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2009
Decision Date November 10, 2009
Days to Decision 194 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
54d slower than avg
Panel avg: 140d · This submission: 194d
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 191
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