Cleared Traditional

K071171 - VPAP AUTO WITH H3I

K071171 is the FDA 510(k) clearance for VPAP AUTO WITH H3I by Resmed, Ltd.. It is a Class 2 Anesthesiology device (product code BZD) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K071171 · Resmed, Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
74d
Days
Class 2
Risk

K071171 is an FDA 510(k) clearance for the VPAP AUTO WITH H3I. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Resmed, Ltd. (Poway, US). The FDA issued a Cleared decision on July 10, 2007 after a review of 74 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 Resmed, Ltd. devices

Submission Details

510(k) Number K071171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2007
Decision Date July 10, 2007
Days to Decision 74 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
66d faster than avg
Panel avg: 140d · This submission: 74d
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 246
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K071171.
MIRAGE MICRO
K072940 · Resmed, Ltd. · Dec 2007
MIRAGE MICRO
K071808 · Resmed, Ltd. · Oct 2007
RESTRAXX DATA CENTRE, MODEL R10
K070746 · Resmed, Ltd. · Jul 2007
TWILIGHT FULL FACE MASK
K070321 · Invacare Corp. · Apr 2007
MIRAGE LIBERTY FULL FACE MASK
K063011 · Resmed, Ltd. · Feb 2007
MIRAGE QUATTRO FULL FACE MASK
K063122 · Resmed, Ltd. · Feb 2007