Cleared Traditional

K903570 - SINGLE PATIENT USE INFANT DISPOSABLE MA...

K903570 is an FDA 510(k) clearance for SINGLE PATIENT USE INFANT DISPOSABLE MA..., 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 10-day FDA review.

K903570 · Puritan Bennett Corp. · Anesthesiology device
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Aug 1990
Decision
10d
Days
Class 2
Risk

K903570 is an FDA 510(k) clearance for the SINGLE PATIENT USE INFANT DISPOSABLE MANUAL RESUSC. 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 17, 1990 after a review of 10 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 - K903570

510(k) Number K903570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1990
Decision Date August 17, 1990
Days to Decision 10 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d faster than avg
Panel avg: 140d · This submission: 10d
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 K903570.
1ST RESPONSE (TM) INFANT MANUAL RESUSCITATOR
K902733 · Intertech Resources, Inc. · Aug 1990
MOD PURITAN BENNETT SING PATIENT DISPOS MAN RESUS
K903438 · Puritan Bennett Corp. · Aug 1990
MODIFIED SINGLE PATIENT USE DISP MAN RESUSCITATOR
K903443 · Puritan Bennett Corp. · Aug 1990
INFANT MANUAL RESUSCITATOR (PMR 2)
K903631 · Puritan Bennett Corp. · Aug 1990
1ST RESPONSE REUSABLE MANUAL RESUSCITATOR (ADULT)
K900577 · Intertech Resources, Inc. · Jul 1990
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR) INFANT
K902261 · Ambu, Inc. · Jul 1990