Cleared Traditional

K905002 - SINGLE USE MANUAL RESUSCITATORS

K905002 is the FDA 510(k) clearance for SINGLE USE MANUAL RESUSCITATORS by Custom Medical, Inc.. It is a Class 2 Anesthesiology device (product code BTM) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K905002 · Custom Medical, Inc. · Anesthesiology device
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Mar 1991
Decision
142d
Days
Class 2
Risk

K905002 is an FDA 510(k) clearance for the SINGLE USE MANUAL RESUSCITATORS. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Custom Medical, Inc. (Bloomington, US). The FDA issued a Cleared decision on March 29, 1991 after a review of 142 days - within the typical 510(k) review window.

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 Custom Medical, Inc. devices

Submission Details

510(k) Number K905002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1990
Decision Date March 29, 1991
Days to Decision 142 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 140d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 33
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K905002.
MOUTH TO MASK RESUSCITATOR
K912625 · Vital Signs, Inc. · Aug 1991
VITAL SIGNS CODE BLUE ADULT MANUAL RESUSCITATOR
K904899 · Vital Signs, Inc. · Jul 1991
MANUAL RESUSCITATOR
K910856 · Vital Signs, Inc. · Jun 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