Cleared Traditional

K904899 - VITAL SIGNS CODE BLUE ADULT MANUAL RESU...

K904899 is the FDA 510(k) clearance for VITAL SIGNS CODE BLUE ADULT MANUAL RESU... by Vital Signs, Inc.. It is a Class 2 Anesthesiology device (product code BTM) cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K904899 · Vital Signs, Inc. · Anesthesiology device
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Jul 1991
Decision
267d
Days
Class 2
Risk

K904899 is an FDA 510(k) clearance for the VITAL SIGNS CODE BLUE ADULT MANUAL RESUSCITATOR. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Vital Signs, Inc. (Totowa, US). The FDA issued a Cleared decision on July 24, 1991 after a review of 267 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 Vital Signs, Inc. devices

Submission Details

510(k) Number K904899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1990
Decision Date July 24, 1991
Days to Decision 267 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
127d slower than avg
Panel avg: 140d · This submission: 267d
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 74
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K904899.
MODIFICATION MANUAL RESUSCITATOR (PMR 2)
K913370 · Puritan Bennett Corp. · Aug 1991
MODIFIED SINGLE PATIENT USE DISP. MANUAL RESUSCIT.
K911971 · Puritan Bennett Corp. · Aug 1991
MOUTH TO MASK RESUSCITATOR
K912625 · Vital Signs, Inc. · Aug 1991
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