Cleared Traditional

K940739 - NEWPORT COMMUNICAT PROTOCOL INTERFACE A...

K940739 is an FDA 510(k) clearance for NEWPORT COMMUNICAT PROTOCOL INTERFACE A..., manufactured by Newport Medical Instruments, Inc.. The device is a Class 2 Anesthesiology device with product code MOD cleared through the Traditional 510(k) pathway after a 383-day FDA review.

K940739 · Newport Medical Instruments, Inc. · Anesthesiology device
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Mar 1995
Decision
383d
Days
Class 2
Risk

K940739 is an FDA 510(k) clearance for the NEWPORT COMMUNICAT PROTOCOL INTERFACE ADAPTOR. Classified as Accessory To Continuous Ventilator (respirator) (product code MOD), Class II - Special Controls.

Submitted by Newport Medical Instruments, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on March 7, 1995 after a review of 383 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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. Elevated predicate reliance profile. 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 Newport Medical Instruments, Inc. devices

FDA 510(k) Submission Details - K940739

510(k) Number K940739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1994
Decision Date March 07, 1995
Days to Decision 383 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
243d slower than avg
Panel avg: 140d · This submission: 383d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOD Device Classification - Class 2, Special Controls

Product Code MOD Accessory To Continuous Ventilator (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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.