Cleared Traditional

K140049 - MOVES SLC

K140049 is an FDA 510(k) clearance for MOVES SLC, manufactured by Thornhill Research, Inc.. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K140049 · Thornhill Research, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
140d
Days
Class 2
Risk

K140049 is an FDA 510(k) clearance for the MOVES SLC. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Thornhill Research, Inc. (Toronto, CA). The FDA issued a Cleared decision on May 29, 2014 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5925 - 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 Thornhill Research, Inc. devices

FDA 510(k) Submission Details - K140049

510(k) Number K140049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2014
Decision Date May 29, 2014
Days to Decision 140 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
At panel average
Panel avg: 140d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTL Device Classification - Class 2, Special Controls

Product Code BTL Ventilator, Emergency, Powered (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5925
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 - BTL Ventilator, Emergency, Powered (resuscitator)

All 68
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K140049.
VORTRAN GO2VENT
K162968 · Vortran Medical Technology 1, Inc. · Apr 2017
O-TWO E700,O-TWO E600,O-TWO E500
K141595 · O-Two Medical Technologies, Inc. · Mar 2015
T-PIECE RESUSCITATOR
K142096 · Mercury Medical · Oct 2014
LIFEBORNE INFANT RESUSCITATOR
K140707 · International Biomedical · May 2014
EMERGENCY PORTABLE VENTILATOR
K131098 · Allied Healthcare Products, Inc. · Apr 2014
AHP 300, EMERGENCY PORTABLE VENTILATOR
K132021 · Allied Healthcare Products, Inc. · Apr 2014