Cleared Traditional

K051364 - VPAP ADAPT

K051364 is the FDA 510(k) clearance for VPAP ADAPT by Resmed, Ltd.. It is a Class 2 Anesthesiology device (product code MNS) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K051364 · Resmed, Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
83d
Days
Class 2
Risk

K051364 is an FDA 510(k) clearance for the VPAP ADAPT. Classified as Ventilator, Continuous, Non-life-supporting (product code MNS), Class II - Special Controls.

Submitted by Resmed, Ltd. (Poway, US). The FDA issued a Cleared decision on August 16, 2005 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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 K051364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2005
Decision Date August 16, 2005
Days to Decision 83 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
57d faster than avg
Panel avg: 140d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNS Ventilator, Continuous, Non-life-supporting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - MNS Ventilator, Continuous, Non-life-supporting

All 35
Devices cleared under the same product code (MNS) and FDA review panel - the closest regulatory comparables to K051364.
BIPAP AUTOSV
K063540 · Respironics, Inc. · Feb 2007
BIPAP SYNCHRONY
K063533 · Respironics, Inc. · Feb 2007
VPAP III ST-A/KIDSTA MASK SYSTEM
K060105 · Resmed, Ltd. · Apr 2006
VPAP III ST-A
K033276 · Resmed, Ltd. · Jun 2004
BIPAP HARMONY VENTILATORY SUPPORT SYSTEM
K031656 · Respironics, Inc. · Jul 2003
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX
K020777 · Respironics, Inc. · Mar 2002