Cleared Traditional

K042556 - SHINEBALL PVC MANUAL RESUSCIATOR

K042556 is an FDA 510(k) clearance for SHINEBALL PVC MANUAL RESUSCIATOR, manufactured by Enter Medical Corporation. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K042556 · Enter Medical Corporation · Anesthesiology device
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Mar 2005
Decision
172d
Days
Class 2
Risk

K042556 is an FDA 510(k) clearance for the SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SIL.... Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Enter Medical Corporation (Gui Shan Xiang,Tao Yuan Hsien, TW). The FDA issued a Cleared decision on March 11, 2005 after a review of 172 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 Enter Medical Corporation devices

FDA 510(k) Submission Details - K042556

510(k) Number K042556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2004
Decision Date March 11, 2005
Days to Decision 172 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 140d · This submission: 172d
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 102
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K042556.
RESUSCITATION TIMER, MODEL L770-CPR
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K042682 · Ambu, Inc. · Nov 2004
AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS
K042843 · Ambu, Inc. · Nov 2004
1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR
K023793 · Portex, Inc. · Feb 2003