Cleared Traditional

K150111 - Apex Medical Corp. iCH CPAP with PVA 9S...

K150111 is the FDA 510(k) clearance for Apex Medical Corp. iCH CPAP with PVA 9S... by Apex Medical Corp.. It is a Class 2 Anesthesiology device (product code BZD) cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K150111 · Apex Medical Corp. · Anesthesiology device
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Sep 2015
Decision
238d
Days
Class 2
Risk

K150111 is an FDA 510(k) clearance for the Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Apex Medical Corp. (New Taipei County, TW). The FDA issued a Cleared decision on September 15, 2015 after a review of 238 days - an extended review cycle.

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

Submission Details

510(k) Number K150111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2015
Decision Date September 15, 2015
Days to Decision 238 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
98d slower than avg
Panel avg: 140d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 266
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K150111.
Simple T Pediatric Nasal Mask
K151120 · Respironics, Inc. · Apr 2016
Sapphire
K152356 · Respironics, Inc. · Jan 2016
AF541 EE Full Face Mask
K150639 · Respironics, Inc. · Sep 2015
CPAP Cannulaide
K143700 · Salter Labs · Aug 2015
Darlinghurst Vented, Darlinghurst NV-AAV
K143603 · Resmed, Ltd. · May 2015
TI NASAL MASK
K140980 · Respironics, Inc. · Feb 2015