Cleared Traditional

K913900 - V*CARE MANUAL RESUSCITATOR

K913900 is an FDA 510(k) clearance for V*CARE MANUAL RESUSCITATOR, manufactured by Ventlab Corp.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K913900 · Ventlab Corp. · Anesthesiology device
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Jan 1992
Decision
130d
Days
Class 2
Risk

K913900 is an FDA 510(k) clearance for the V*CARE MANUAL RESUSCITATOR, CAT#VR-1000. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Ventlab Corp. (Bound Brook, US). The FDA issued a Cleared decision on January 7, 1992 after a review of 130 days - within the typical 510(k) review window.

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 Ventlab Corp. devices

FDA 510(k) Submission Details - K913900

510(k) Number K913900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1991
Decision Date January 07, 1992
Days to Decision 130 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 140d · This submission: 130d
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 83
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K913900.
SPUR INFANT/CHILD WITH OPEN RESERVOIR SYSTEM
K922712 · Ambu, Inc. · Jun 1992
MODIFICATION PURITAN-BENNETT INFANT PM2
K922004 · Puritan Bennett Corp. · May 1992
PURITAN-BENNET INFANT MANUAL RESUSCITATOR MODIFIED
K920570 · Puritan Bennett Corp. · Feb 1992
AMBU SILICONE RESUSCITATOR INFANT/CHILD
K914187 · Ambu, Inc. · Oct 1991
MODIFICATION MANUAL RESUSCITATOR (PMR 2)
K913370 · Puritan Bennett Corp. · Aug 1991
MODIFIED SINGLE PATIENT USE DISP. MANUAL RESUSCIT.
K911971 · Puritan Bennett Corp. · Aug 1991