Cleared Traditional

K964584 - AMBU SPUR NEONATE

K964584 is an FDA 510(k) clearance for AMBU SPUR NEONATE, manufactured by Ambu, Inc.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K964584 · Ambu, Inc. · Anesthesiology device
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May 1997
Decision
181d
Days
Class 2
Risk

K964584 is an FDA 510(k) clearance for the AMBU SPUR NEONATE. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Ambu, Inc. (Linthicum, US). The FDA issued a Cleared decision on May 15, 1997 after a review of 181 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 Ambu, Inc. devices

FDA 510(k) Submission Details - K964584

510(k) Number K964584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1996
Decision Date May 15, 1997
Days to Decision 181 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 140d · This submission: 181d
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 142
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K964584.
MANUAL RESUSCITATOR
K963848 · Owens-Brigam Medical Co. · Jul 1997
DATEX ENGSTOM MANUAL RESUSCITATOR
K970991 · Promedic, Inc. · Jun 1997
INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT)
K970959 · Instrumentation Industries, Inc. · Jun 1997
HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR
K964719 · Hudson Respiratory Care, Inc. · Feb 1997
GRAYCO POCKET PUMP
K955507 · Grayco, Inc. · Aug 1996
BAGRIGHT CHILD RESUSCITATOR
K961329 · Medical Marketing Concepts · Jul 1996