Cleared Traditional

GALEMED CPAP MASK (K072755) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K072755 · Galemed Corp. · Anesthesiology device
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Nov 2007
Decision
50d
Days
Class 2
Risk

K072755 is an FDA 510(k) clearance for the GALEMED CPAP MASK. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Galemed Corp. (Bonita Springs, US). The FDA issued a Cleared decision on November 16, 2007 after a review of 50 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Galemed Corp. devices

Submission Details

510(k) Number K072755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2007
Decision Date November 16, 2007
Days to Decision 50 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
90d faster than avg
Panel avg: 140d · This submission: 50d
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 119
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K072755.
RESPIRONICS SLEEPEASY CPAP SYSTEM
K091112 · Respironics, Inc. · May 2009
COMFORTLITE NASAL MASK
K082558 · Respironics, Inc. · Mar 2009
REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM
K072996 · Respironics, Inc. · Dec 2007
BIPAP PLUS M-SERIES BI-LEVEL SYSTEM
K061034 · Respironics, Inc. · Jun 2006
COMFORTLITE NASAL MASK
K053352 · Respironics, Inc. · Feb 2006
M-SERIES PRO CPAP SYTEM
K052110 · Respironics, Inc. · Oct 2005