Cleared Special

K011874 - FADASIS MEDICAL FM-1 NO BLENDER

K011874 is an FDA 510(k) clearance for FADASIS MEDICAL FM-1 NO BLENDER, manufactured by Fadasis Medical, Inc.. The device is a Class 2 Anesthesiology device with product code MRO cleared through the Special 510(k) pathway after a 35-day FDA review.

K011874 · Fadasis Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
35d
Days
Class 2
Risk

K011874 is an FDA 510(k) clearance for the FADASIS MEDICAL FM-1 NO BLENDER. Classified as Apparatus, Nitric Oxide, Backup Delivery (product code MRO), Class II - Special Controls.

Submitted by Fadasis Medical, Inc. (Middleton, US). The FDA issued a Cleared decision on July 20, 2001 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5165 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K011874

510(k) Number K011874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2001
Decision Date July 20, 2001
Days to Decision 35 days
Submission Type Special
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
105d faster than avg
Panel avg: 140d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

MRO Device Classification - Class 2, Special Controls

Product Code MRO Apparatus, Nitric Oxide, Backup Delivery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5165
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.

K011874 · FADASIS MEDICAL FM-1 NO BLENDER
Download PDF FDA Summary Fadasis Medical, Inc.