Cleared Traditional

K161420 - MOVES SLC

K161420 is the FDA 510(k) clearance for MOVES SLC by Thornhill Research, Inc.. It is a Class 2 Anesthesiology device (product code BTL) cleared through the Traditional 510(k) pathway after a 379-day FDA review.

K161420 · Thornhill Research, Inc. · Anesthesiology device
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Jun 2017
Decision
379d
Days
Class 2
Risk

K161420 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 June 6, 2017 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K161420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2016
Decision Date June 06, 2017
Days to Decision 379 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
239d slower than avg
Panel avg: 140d · This submission: 379d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 11
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K161420.
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K070210 · Ohmeda Medical · Apr 2007
MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR
K991785 · Instrumentation Industries, Inc. · Aug 1999
OHMEDA - LOGIC 07A TRANSPORT VENTILATOR
K901846 · Ohmeda Medical · Aug 1990