Cleared Traditional

K113640 - STELLAR 150

K113640 is an FDA 510(k) clearance for STELLAR 150, manufactured by Resmed Germany, Inc.. The device is a Class 2 Anesthesiology device with product code MNT cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K113640 · Resmed Germany, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
118d
Days
Class 2
Risk

K113640 is an FDA 510(k) clearance for the STELLAR 150. Classified as Ventilator, Continuous, Minimal Ventilatory Support, Facility Use (product code MNT), Class II - Special Controls.

Submitted by Resmed Germany, Inc. (San Diego, US). The FDA issued a Cleared decision on April 5, 2012 after a review of 118 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K113640

510(k) Number K113640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2011
Decision Date April 05, 2012
Days to Decision 118 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
22d faster than avg
Panel avg: 140d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNT Device Classification - Class 2, Special Controls

Product Code MNT Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
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 - MNT Ventilator, Continuous, Minimal Ventilatory Support, Facility Use

All 24
Devices cleared under the same product code (MNT) and FDA review panel - the closest regulatory comparables to K113640.
Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small
K170367 · Fisher and Paykel Healthcare Limited · Aug 2017
STELLAR 150
K122715 · Resmed Germany, Inc. · Jun 2013
BIPAP A 40 VENTILATORY SUPPORT SYSTEM
K121623 · Respironics, Inc. · Dec 2012
V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS
K102985 · Respironics, Inc. · Apr 2011
STELLAR 150
K103167 · Resmed Germany, Inc. · Mar 2011
BREAS VIVO 40 SYSTEM
K090113 · Breas Medical AB · May 2009