Cleared Special

BREEZE SLEEPGEAR WITH DREAMSEAL (K002001) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K002001 · Puritan Bennett Corp. · Anesthesiology device
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Sep 2000
Decision
68d
Days
Class 2
Risk

K002001 is an FDA 510(k) clearance for the BREEZE SLEEPGEAR WITH DREAMSEAL. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Puritan Bennett Corp. (Minneapolis, US). The FDA issued a Cleared decision on September 6, 2000 after a review of 68 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Puritan Bennett Corp. devices

Submission Details

510(k) Number K002001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2000
Decision Date September 06, 2000
Days to Decision 68 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 140d · This submission: 68d
Pathway characteristics
Modification to existing cleared device.

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 K002001.
REMSTAR PLUS CPAP SYSTEM
K010263 · Respironics, Inc. · Mar 2001
RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223
K000705 · Respironics, Inc. · Sep 2000
SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876
K002465 · Respironics, Inc. · Sep 2000
BIPAP DUET LX BI-LEVEL SYSTEM
K000994 · Respironics, Inc. · Jun 2000
RESPIRONICS TOTAL FACE MASK
K992969 · Respironics, Inc. · Nov 1999
ARIA LX CPAP SYSTEM
K993307 · Respironics, Inc. · Oct 1999