Cleared Traditional

K041852 - MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002

K041852 is an FDA 510(k) clearance for MR TESTED FIBER OPTIC SHORT LARYNGOSCOP..., manufactured by Minrad, Inc.. The device is a Class 1 Anesthesiology device with product code CCW cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K041852 · Minrad, Inc. · Anesthesiology device
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Nov 2004
Decision
130d
Days
Class 1
Risk

K041852 is an FDA 510(k) clearance for the MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002. Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by Minrad, Inc. (Buffalo, US). The FDA issued a Cleared decision on November 15, 2004 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5540 - 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 Minrad, Inc. devices

FDA 510(k) Submission Details - K041852

510(k) Number K041852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2004
Decision Date November 15, 2004
Days to Decision 130 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 140d · This submission: 130d
Pathway characteristics
Predicate-based equivalence.

CCW Device Classification - Class 1, General Controls

Product Code CCW Laryngoscope, Rigid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CCW Laryngoscope, Rigid

All 28
Devices cleared under the same product code (CCW) and FDA review panel - the closest regulatory comparables to K041852.
TRU-MR LARYNGOSCOPE SET
K062523 · Truphatek International, Ltd. · Nov 2006
MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002
K062230 · Minrad, Inc. · Aug 2006
MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001
K062231 · Minrad, Inc. · Aug 2006
FLEXIBLADE
K984101 · Arco Medic , Ltd. · Sep 1999
GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE
K971377 · Wilson Greatbatch Technologies, Inc. · Apr 1998
GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE
K970619 · Wilson Greatbatch Technologies, Inc. · Nov 1997