Cleared Traditional

K993278 - AMBU NEONATE SILICONE RESUSCITATOR

K993278 is an FDA 510(k) clearance for AMBU NEONATE SILICONE RESUSCITATOR, 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 230-day FDA review.

K993278 · Ambu, Inc. · Anesthesiology device
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May 2000
Decision
230d
Days
Class 2
Risk

K993278 is an FDA 510(k) clearance for the AMBU NEONATE SILICONE RESUSCITATOR. 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 17, 2000 after a review of 230 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 - K993278

510(k) Number K993278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1999
Decision Date May 17, 2000
Days to Decision 230 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
90d slower than avg
Panel avg: 140d · This submission: 230d
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 K993278.
V*CARE MANUAL RESUSCITATOR
K012842 · Ventlab Corp. · Sep 2001
Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02
K003927 · Cheen Houng Ent. Co. , Ltd. · Jun 2001
HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR
K002846 · Headstar Medical Products Co., Ltd. · Jun 2001
RUSCH MANUAL RESUSCITATOR BAG
K993194 · Rusch, Inc. · Mar 2000
1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE
K991861 · Sims Portex, Inc. · Jan 2000
IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006
K992057 · Sims Portex, Inc. · Sep 1999