Cleared Traditional

K073410 - SAVE RESUSCITATOR

K073410 is an FDA 510(k) clearance for SAVE RESUSCITATOR, manufactured by Artivent Corporation. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K073410 · Artivent Corporation · Anesthesiology device
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Sep 2008
Decision
283d
Days
Class 2
Risk

K073410 is an FDA 510(k) clearance for the SAVE RESUSCITATOR. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Artivent Corporation (Irvine, US). The FDA issued a Cleared decision on September 12, 2008 after a review of 283 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5915 - 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 Artivent Corporation devices

FDA 510(k) Submission Details - K073410

510(k) Number K073410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2007
Decision Date September 12, 2008
Days to Decision 283 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
143d slower than avg
Panel avg: 140d · This submission: 283d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTM Device Classification - Class 2, Special Controls

Product Code BTM Ventilator, Emergency, Manual (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5915
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 - BTM Ventilator, Emergency, Manual (resuscitator)

All 102
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K073410.
Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer
K170663 · Foremount Enterprise Co., Ltd. · May 2018
Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator
K152931 · Ambu A/S · Aug 2016
AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC
K102824 · Ambu A/S · Jan 2011
RESUSCITATION TIMER, MODEL L770-CPR
K073171 · Allied Healthcare Products, Inc. · Jan 2008
GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM
K070247 · Ohmeda Medical · Apr 2007
RESUSCITATION TIMER, MODEL L770-CPR
K062080 · Allied Healthcare Products, Inc. · Oct 2006