Cleared Traditional

BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003 (K061099) - FDA 510(k) Clearance

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

K061099 · Hoffman Laboratories, LLC · Anesthesiology device
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Aug 2006
Decision
114d
Days
Class 2
Risk

K061099 is an FDA 510(k) clearance for the BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Hoffman Laboratories, LLC (Chatsworth, US). The FDA issued a Cleared decision on August 11, 2006 after a review of 114 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 Hoffman Laboratories, LLC devices

Submission Details

510(k) Number K061099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2006
Decision Date August 11, 2006
Days to Decision 114 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
26d faster than avg
Panel avg: 140d · This submission: 114d
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 208
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K061099.
MIRAGE QUATTRO FULL FACE MASK
K063122 · Resmed, Ltd. · Feb 2007
VPAP MALIBU WITH H2I
K062291 · Resmed, Ltd. · Sep 2006
INVACARE'S TWILIGHT II NASAL MASKS
K061874 · Invacare Corp. · Sep 2006
PRESTIGE CPAP FLOW GENERATOR WITH PRESTIGE HUMIDIFIER
K061200 · Resmed, Ltd. · Jul 2006
BIPAP PLUS M-SERIES BI-LEVEL SYSTEM
K061034 · Respironics, Inc. · Jun 2006
COMFORTLITE NASAL MASK
K053352 · Respironics, Inc. · Feb 2006