Cleared Traditional

K902733 - 1ST RESPONSE (TM) INFANT MANUAL RESUSCI...

K902733 is an FDA 510(k) clearance for 1ST RESPONSE (TM) INFANT MANUAL RESUSCI..., manufactured by Intertech Resources, Inc.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K902733 · Intertech Resources, Inc. · Anesthesiology device
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Aug 1990
Decision
62d
Days
Class 2
Risk

K902733 is an FDA 510(k) clearance for the 1ST RESPONSE (TM) INFANT MANUAL RESUSCITATOR. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Intertech Resources, Inc. (Fort Myers, US). The FDA issued a Cleared decision on August 22, 1990 after a review of 62 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 Intertech Resources, Inc. devices

FDA 510(k) Submission Details - K902733

510(k) Number K902733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1990
Decision Date August 22, 1990
Days to Decision 62 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
78d faster than avg
Panel avg: 140d · This submission: 62d
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 76
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K902733.
PRESSURE LIMITING ELBOW WITH MANOMETER PORT
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MANUAL RESUSCITATOR
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K910040 · Ambu, Inc. · May 1991
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
SINGLE PATIENT USE INFANT DISPOSABLE MANUAL RESUSC
K903570 · Puritan Bennett Corp. · Aug 1990