Cleared Traditional

K023683 - MULTI-STRAP FULL FACE MASK

K023683 is an FDA 510(k) clearance for MULTI-STRAP FULL FACE MASK, manufactured by Engineered Medical Systems. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 395-day FDA review.

K023683 · Engineered Medical Systems · Anesthesiology device
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Dec 2003
Decision
395d
Days
Class 2
Risk

K023683 is an FDA 510(k) clearance for the MULTI-STRAP FULL FACE MASK. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Engineered Medical Systems (Mccordsville, US). The FDA issued a Cleared decision on December 1, 2003 after a review of 395 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Engineered Medical Systems devices

FDA 510(k) Submission Details - K023683

510(k) Number K023683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2002
Decision Date December 01, 2003
Days to Decision 395 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
255d slower than avg
Panel avg: 140d · This submission: 395d
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 288
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K023683.
APEX MEDICAL CPAP RT 21XX
K022650 · Apex Medical Corp. · Feb 2004
ORACLE ORAL MASK, MODEL HC451A
K033087 · Fisher &Paykel Healthcare , Ltd. · Jan 2004
MIRAGE ACTIVA MASK
K032916 · Resmed, Ltd. · Dec 2003
NASAL JACKS MASK
K032433 · Resmed, Ltd. · Oct 2003
AUTOSET SPIRIT SYSTEM
K032480 · Resmed, Ltd. · Oct 2003
BREAS PV 10I CPAP SYSTEM, MODEL PV 10I
K030985 · Vital Signs, Inc. · Oct 2003