Cleared Traditional

K031370 - SHINMED MODE SW-988 UNTRASONIC NEBULIZER

K031370 is an FDA 510(k) clearance for SHINMED MODE SW-988 UNTRASONIC NEBULIZER, manufactured by Shining World Health Care Co., Ltd.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 490-day FDA review.

K031370 · Shining World Health Care Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
490d
Days
Class 2
Risk

K031370 is an FDA 510(k) clearance for the SHINMED MODE SW-988 UNTRASONIC NEBULIZER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Shining World Health Care Co., Ltd. (Hsin Chu City, TW). The FDA issued a Cleared decision on September 1, 2004 after a review of 490 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Shining World Health Care Co., Ltd. devices

FDA 510(k) Submission Details - K031370

510(k) Number K031370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2003
Decision Date September 01, 2004
Days to Decision 490 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
350d slower than avg
Panel avg: 140d · This submission: 490d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

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 210
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K031370.
APEX MEDICAL MININEB & MINIPLUS
K050104 · Apex Medical Corp. · Feb 2005
INVACARE PRO, COMPACT AND PORTABLE DESKTOP
K042483 · Invacare Corporation · Jan 2005
NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER
K041082 · Newport Medical Instruments, Inc. · Sep 2004
AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER
K041418 · Cardinalhealth · Jun 2004
OMNI~NEB
K030396 · B&B Medical Technologies, Inc. · May 2004
HIOX80 AEROSOL ADAPTER
K032516 · Sensor Medics Corp. · Mar 2004