Cleared Traditional

K072255 - MINRAD INC. NASAL SCAVENGING CIRCUIT

K072255 is an FDA 510(k) clearance for MINRAD INC. NASAL SCAVENGING CIRCUIT, manufactured by Minrad, Inc.. The device is a Class 2 Anesthesiology device with product code CBN cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K072255 · Minrad, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
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Oct 2007
Decision
66d
Days
Class 2
Risk

K072255 is an FDA 510(k) clearance for the MINRAD INC. NASAL SCAVENGING CIRCUIT. Classified as Apparatus, Gas-scavenging (product code CBN), Class II - Special Controls.

Submitted by Minrad, Inc. (Orchard Park, US). The FDA issued a Cleared decision on October 18, 2007 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5430 - 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.

View all Minrad, Inc. devices

FDA 510(k) Submission Details - K072255

510(k) Number K072255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2007
Decision Date October 18, 2007
Days to Decision 66 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
74d faster than avg
Panel avg: 140d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBN Device Classification - Class 2, Special Controls

Product Code CBN Apparatus, Gas-scavenging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5430
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 - CBN Apparatus, Gas-scavenging

All 13
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