Cleared Traditional

K920570 - PURITAN-BENNET INFANT MANUAL RESUSCITAT...

K920570 is an FDA 510(k) clearance for PURITAN-BENNET INFANT MANUAL RESUSCITAT..., 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 20-day FDA review.

K920570 · Puritan Bennett Corp. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Feb 1992
Decision
20d
Days
Class 2
Risk

K920570 is an FDA 510(k) clearance for the PURITAN-BENNET INFANT MANUAL RESUSCITATOR MODIFIED. 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 February 27, 1992 after a review of 20 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 - K920570

510(k) Number K920570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1992
Decision Date February 27, 1992
Days to Decision 20 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 140d · This submission: 20d
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 K920570.
SPUR ADULT WITH OPEN RESERVOIR SYSTEM
K922707 · Ambu, Inc. · Jun 1992
SPUR INFANT/CHILD WITH OPEN RESERVOIR SYSTEM
K922712 · Ambu, Inc. · Jun 1992
MODIFICATION PURITAN-BENNETT INFANT PM2
K922004 · Puritan Bennett Corp. · May 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