Cleared Traditional

K030985 - BREAS PV 10I CPAP SYSTEM, MODEL PV 10I

K030985 is an FDA 510(k) clearance for BREAS PV 10I CPAP SYSTEM, manufactured by Vital Signs, Inc.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K030985 · Vital Signs, Inc. · Anesthesiology device
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Oct 2003
Decision
201d
Days
Class 2
Risk

K030985 is an FDA 510(k) clearance for the BREAS PV 10I CPAP SYSTEM, MODEL PV 10I. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Vital Signs, Inc. (Totowa, US). The FDA issued a Cleared decision on October 15, 2003 after a review of 201 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 Vital Signs, Inc. devices

FDA 510(k) Submission Details - K030985

510(k) Number K030985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2003
Decision Date October 15, 2003
Days to Decision 201 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
61d slower than avg
Panel avg: 140d · This submission: 201d
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 428
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K030985.
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AUTOSET SPIRIT SYSTEM
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ARABELLA NCPAP MASKS
K030563 · Hamilton Medical AG · Sep 2003
LYRA NASAL MASK
K031883 · Sensor Medics Corp. · Aug 2003
MIRAGE VISTA MASK
K031047 · Resmed, Ltd. · Aug 2003