Cleared Traditional

K881648 - TRANSFER CONTAINER HUMIDIFIER

K881648 is the FDA 510(k) clearance for TRANSFER CONTAINER HUMIDIFIER by Newport Biosystems, Inc.. It is a Class 2 Anesthesiology device (product code CAF) cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K881648 · Newport Biosystems, Inc. · Anesthesiology device
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Dec 1988
Decision
259d
Days
Class 2
Risk

K881648 is an FDA 510(k) clearance for the TRANSFER CONTAINER HUMIDIFIER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Newport Biosystems, Inc. (Redwood City, US). The FDA issued a Cleared decision on December 30, 1988 after a review of 259 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - 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 Newport Biosystems, Inc. devices

Submission Details

510(k) Number K881648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1988
Decision Date December 30, 1988
Days to Decision 259 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 140d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
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 - CAF Nebulizer (direct Patient Interface)

All 135
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K881648.
DP 100
K911192 · Ferguson Medical · Dec 1991
MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD
K894138 · Medipart Jerry Alexander · Sep 1989
HAND HELD NEBULIZER SYSTEM
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OMRON ULTRASONIC NEBULIZER NE-U06
K875134 · Nidek, Inc. · Dec 1988
AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER
K883964 · Baxter Healthcare Corp · Nov 1988
MICROCIRRUS MEDICAL NEBULIZER
K881935 · Dhd Medical Products Div. Diemolding Corp. · Jun 1988