Cleared Traditional

K941308 - NEWPORT ELECTRONIC MANOMETER

K941308 is an FDA 510(k) clearance for NEWPORT ELECTRONIC MANOMETER, manufactured by Newport Medical Instruments, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 536-day FDA review.

K941308 · Newport Medical Instruments, Inc. · Anesthesiology device
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Aug 1995
Decision
536d
Days
Class 2
Risk

K941308 is an FDA 510(k) clearance for the NEWPORT ELECTRONIC MANOMETER. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Newport Medical Instruments, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on August 25, 1995 after a review of 536 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Newport Medical Instruments, Inc. devices

FDA 510(k) Submission Details - K941308

510(k) Number K941308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received March 07, 1994
Decision Date August 25, 1995
Days to Decision 536 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
396d slower than avg
Panel avg: 140d · This submission: 536d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
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.

Regulatory Peers - CBK Ventilator, Continuous, Facility Use

All 274
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K941308.
MODEL LP-1000 VOLUME VENTILATOR
K952880 · Aequitron Medical, Inc. · Jun 1996
TBIRD VS VENTILATOR AND TBIRD AVS VENTILATOR
K950484 · Bird Products Corp. · May 1996
NARKOMED AV2+ ANESTHESIA VENTILATOR
K953228 · Draeger Medical, Inc. · Mar 1996
NEWPORT ELECTRONIC MANOMETER
K941309 · Newport Medical Instruments, Inc. · Mar 1995
MODEL 7200AE VENTILATOR
K922705 · Puritan Bennett Corp. · Sep 1994
MODEL 7200AE VENTILATOR (ENHANCEMENT)
K922975 · Puritan Bennett Corp. · Sep 1994