Cleared Traditional

K112914 - VPAP TX

K112914 is the FDA 510(k) clearance for VPAP TX by Resmed, Ltd.. It is a Class 2 Anesthesiology device (product code MNS) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K112914 · Resmed, Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
87d
Days
Class 2
Risk

K112914 is an FDA 510(k) clearance for the VPAP TX. Classified as Ventilator, Continuous, Non-life-supporting (product code MNS), Class II - Special Controls.

Submitted by Resmed, Ltd. (San Diego, US). The FDA issued a Cleared decision on December 29, 2011 after a review of 87 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 K112914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2011
Decision Date December 29, 2011
Days to Decision 87 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
53d faster than avg
Panel avg: 140d · This submission: 87d
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 K112914.
VPAP ST-A
K113288 · Resmed, Ltd. · Mar 2012
RESSCAN
K113815 · Resmed, Ltd. · Mar 2012
BIPAP A 30 VENTILATORY SUPPORT SYSTEM
K113053 · Respironics, Inc. · Feb 2012
BIPAP AVAPS VENTILATORY SUPPORT SYSTEM
K102465 · Respironics, Inc. · Mar 2011
BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK
K101130 · Respironics, Inc. · Sep 2010
VPAP III ST-A
K093731 · Resmed, Ltd. · Mar 2010