Cleared Special

APEX MEDICAL CPAP MODEL 9S-003 (K041828) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K041828 · Apex Medical Corp. · Anesthesiology device
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Jul 2004
Decision
23d
Days
Class 2
Risk

K041828 is an FDA 510(k) clearance for the APEX MEDICAL CPAP MODEL 9S-003. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Apex Medical Corp. (Tucheng City, Taipei County, TW). The FDA issued a Cleared decision on July 30, 2004 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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.

View all Apex Medical Corp. devices

Submission Details

510(k) Number K041828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2004
Decision Date July 30, 2004
Days to Decision 23 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 140d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 208
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K041828.
RESMED MERIDIAN MASK
K050142 · Resmed, Ltd. · Mar 2005
BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX
K043607 · Respironics, Inc. · Jan 2005
MIRAGE SWIFT
K042403 · Resmed, Ltd. · Oct 2004
RESMED HOSPITAL FULL FACE MASK
K041362 · Resmed, Ltd. · Jul 2004
RESMED S8 PIONEER CPAP SYSTEM
K041209 · Resmed, Ltd. · Jul 2004
RESCONTROL II
K040944 · Resmed, Ltd. · Jun 2004