Cleared Traditional

K955887 - NEWMED ABP-LITE

K955887 is an FDA 510(k) clearance for NEWMED ABP-LITE, manufactured by Newmed Corp.. The device is a Class 2 Cardiovascular device with product code DXW cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K955887 · Newmed Corp. · Cardiovascular device
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Sep 1996
Decision
252d
Days
Class 2
Risk

K955887 is an FDA 510(k) clearance for the NEWMED ABP-LITE. Classified as System, Phonocatheter, Intracavitary (product code DXW), Class II - Special Controls.

Submitted by Newmed Corp. (Washington, US). The FDA issued a Cleared decision on September 5, 1996 after a review of 252 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1270 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Newmed Corp. devices

FDA 510(k) Submission Details - K955887

510(k) Number K955887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1995
Decision Date September 05, 1996
Days to Decision 252 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
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: 125d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXW Device Classification - Class 2, Special Controls

Product Code DXW System, Phonocatheter, Intracavitary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1270
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 Cardiovascular devices follow this clearance model.