Cleared Traditional Expedited

K093261 - MOVES

K093261 is an FDA 510(k) clearance for MOVES, 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 158-day FDA review.

K093261 · Thornhill Research, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
158d
Days
Class 2
Risk

K093261 is an FDA 510(k) clearance for the MOVES. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Thornhill Research, Inc. (Toronto, Ontario, CA). The FDA issued a Cleared decision on March 26, 2010 after a review of 158 days - an extended review cycle.

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 - K093261

510(k) Number K093261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2009
Decision Date March 26, 2010
Days to Decision 158 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
18d slower than avg
Panel avg: 140d · This submission: 158d
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 69
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K093261.
SAVE II, SAVE II BASIC
K131877 · Automedx, Inc. · Mar 2014
PNEUPAC PARAPAC PLUS
K123957 · Smiths Medical International , Ltd. · Sep 2013
MANUJET III
K112783 · VBM Medizintechnik GmbH · Dec 2011
EMERGENCY PORTABLE VENTILATOR, MODEL EPV200
K090356 · Allied Healthcare Products, Inc. · May 2009
BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS
K083507 · Allied Healthcare Products, Inc. · May 2009
MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B
K083385 · Allied Healthcare Products, Inc. · May 2009