Cleared Traditional

K060193 - MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2

K060193 is an FDA 510(k) clearance for MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, manufactured by Oceanic Medical Products, Inc.. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K060193 · Oceanic Medical Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
75d
Days
Class 2
Risk

K060193 is an FDA 510(k) clearance for the MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Oceanic Medical Products, Inc. (Washington, US). The FDA issued a Cleared decision on April 10, 2006 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K060193

510(k) Number K060193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2006
Decision Date April 10, 2006
Days to Decision 75 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
65d faster than avg
Panel avg: 140d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSZ Device Classification - Class 2, Special Controls

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
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 - BSZ Gas-machine, Anesthesia

All 158
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