Cleared Traditional

K913370 - MODIFICATION MANUAL RESUSCITATOR (PMR 2)

K913370 is an FDA 510(k) clearance for MODIFICATION MANUAL RESUSCITATOR (PMR 2), manufactured by Puritan Bennett Corp.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K913370 · Puritan Bennett Corp. · Anesthesiology device
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Aug 1991
Decision
28d
Days
Class 2
Risk

K913370 is an FDA 510(k) clearance for the MODIFICATION MANUAL RESUSCITATOR (PMR 2). Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Puritan Bennett Corp. (Overland Park, US). The FDA issued a Cleared decision on August 26, 1991 after a review of 28 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Puritan Bennett Corp. devices

FDA 510(k) Submission Details - K913370

510(k) Number K913370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1991
Decision Date August 26, 1991
Days to Decision 28 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 140d · This submission: 28d
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 82
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K913370.
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
MODIFIED SINGLE PATIENT USE DISP. MANUAL RESUSCIT.
K911971 · Puritan Bennett Corp. · Aug 1991
MOUTH TO MASK RESUSCITATOR
K912625 · Vital Signs, Inc. · Aug 1991
VITAL SIGNS CODE BLUE ADULT MANUAL RESUSCITATOR
K904899 · Vital Signs, Inc. · Jul 1991