Cleared Traditional

K905002 - SINGLE USE MANUAL RESUSCITATORS

K905002 is an FDA 510(k) clearance for SINGLE USE MANUAL RESUSCITATORS, manufactured by Custom Medical, Inc.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K905002

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.

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 138
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K905002.
PRESSURE LIMITING ELBOW WITH MANOMETER PORT
K911298 · Intertech Resources, Inc. · Jun 1991
MANUAL RESUSCITATOR
K910856 · Vital Signs, Inc. · Jun 1991
AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT
K910040 · Ambu, Inc. · May 1991
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