Cleared Traditional

K083656 - APEX MEDICAL XT AUTO CPAP 9S-005200

K083656 is an FDA 510(k) clearance for APEX MEDICAL XT AUTO CPAP 9S-005200, manufactured by Apex Medical Corp.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K083656 · Apex Medical Corp. · Anesthesiology device
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Apr 2009
Decision
133d
Days
Class 2
Risk

K083656 is an FDA 510(k) clearance for the APEX MEDICAL XT AUTO CPAP 9S-005200. 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 April 22, 2009 after a review of 133 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K083656

510(k) Number K083656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2008
Decision Date April 22, 2009
Days to Decision 133 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 140d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

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 306
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K083656.
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REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM
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SWIFT FX
K090244 · Resmed, Ltd. · Apr 2009
COMFORTLITE NASAL MASK
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RES TRAXX ONLINE, MODEL: R14
K083816 · Resmed, Ltd. · Mar 2009