Cleared Traditional

K023068 - PAPILLON MASK SET

K023068 is an FDA 510(k) clearance for PAPILLON MASK SET, manufactured by Map Medizintechnik Fur Arzt Und Patient GmbH. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K023068 · Map Medizintechnik Fur Arzt Und Patient GmbH · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
254d
Days
Class 2
Risk

K023068 is an FDA 510(k) clearance for the PAPILLON MASK SET. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Map Medizintechnik Fur Arzt Und Patient GmbH (Poway, US). The FDA issued a Cleared decision on May 28, 2003 after a review of 254 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 Map Medizintechnik Fur Arzt Und Patient GmbH devices

FDA 510(k) Submission Details - K023068

510(k) Number K023068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2002
Decision Date May 28, 2003
Days to Decision 254 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 140d · This submission: 254d
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 307
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K023068.
MODIFICATION TO REMSTAR AUTO CPAP SYSTEM
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SINGLE USE ORAL MASK, MODEL HC455A
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MIRAGE ACTIVA MASK
K030798 · Resmed, Ltd. · Apr 2003
TWLIGHT, MODEL ISP 9600
K022642 · Invacare Corp. · Feb 2003
PEGASUS NASAL CPAP SYSTEM
K022192 · Sensor Medics Corp. · Jan 2003