Cleared Traditional

K900577 - 1ST RESPONSE REUSABLE MANUAL RESUSCITAT...

K900577 is an FDA 510(k) clearance for 1ST RESPONSE REUSABLE MANUAL RESUSCITAT..., 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 159-day FDA review.

K900577 · Intertech Resources, Inc. · Anesthesiology device
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Jul 1990
Decision
159d
Days
Class 2
Risk

K900577 is an FDA 510(k) clearance for the 1ST RESPONSE REUSABLE MANUAL RESUSCITATOR (ADULT). 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 July 16, 1990 after a review of 159 days - an extended review 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: 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 Intertech Resources, Inc. devices

FDA 510(k) Submission Details - K900577

510(k) Number K900577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1990
Decision Date July 16, 1990
Days to Decision 159 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
19d slower than avg
Panel avg: 140d · This submission: 159d
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 K900577.
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
INFANT MANUAL RESUSCITATOR (PMR 2)
K903631 · Puritan Bennett Corp. · Aug 1990
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR) INFANT
K902261 · Ambu, Inc. · Jul 1990
AMBU LIFE KEY AND AMBU RES-CUE KEY
K900260 · Ambu, Inc. · Jun 1990
PURITAN BENNETT SINGLE PATIENT USE PEEP ADAPTER
K900349 · Puritan Bennett Corp. · May 1990