Cleared Traditional

K071221 - SAVE-SIMPLIFIED AUTOMATED VENTILATOR

K071221 is an FDA 510(k) clearance for SAVE-SIMPLIFIED AUTOMATED VENTILATOR, manufactured by Automedx, Inc.. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K071221 · Automedx, Inc. · Anesthesiology device
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Sep 2007
Decision
127d
Days
Class 2
Risk

K071221 is an FDA 510(k) clearance for the SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Automedx, Inc. (Germantown, US). The FDA issued a Cleared decision on September 6, 2007 after a review of 127 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 Automedx, Inc. devices

FDA 510(k) Submission Details - K071221

510(k) Number K071221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2007
Decision Date September 06, 2007
Days to Decision 127 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
13d faster than avg
Panel avg: 140d · This submission: 127d
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 49
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K071221.
MASS CASUALTY VENTILATOR, MODEL MCV100
K080063 · Allied Healthcare Products, Inc. · Aug 2008
VAR MONITOR
K073261 · Vortran Medical Technology 1, Inc. · May 2008
PORTABLE VENTILATOR, MODEL EPV-100
K072214 · Allied Healthcare Products, Inc. · Mar 2008
AUTOVENT 4000 WITH CPAP
K070636 · Allied Healthcare Products, Inc. · Jul 2007
AUTOVENT MODEL 4000
K070120 · Allied Healthcare Products, Inc. · May 2007
GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM
K070210 · Ohmeda Medical · Apr 2007