Cleared Traditional

K881356 - EXTERNAL PACEMAKER WIRE DRESSING CHANGE

K881356 is an FDA 510(k) clearance for EXTERNAL PACEMAKER WIRE DRESSING CHANGE, manufactured by Neal & Assoc., Inc.. The device is a Class 2 Cardiovascular device with product code LDF cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K881356 · Neal & Assoc., Inc. · Cardiovascular device
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May 1988
Decision
52d
Days
Class 2
Risk

K881356 is an FDA 510(k) clearance for the EXTERNAL PACEMAKER WIRE DRESSING CHANGE. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Neal & Assoc., Inc. (Columbia, US). The FDA issued a Cleared decision on May 19, 1988 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Neal & Assoc., Inc. devices

FDA 510(k) Submission Details - K881356

510(k) Number K881356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1988
Decision Date May 19, 1988
Days to Decision 52 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 125d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDF Device Classification - Class 2, Special Controls

Product Code LDF Electrode, Pacemaker, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3680
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.

Regulatory Peers - LDF Electrode, Pacemaker, Temporary

All 93
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K881356.
DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER
K890794 · Daig Corp. · Jun 1989
TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1
K884866 · Oscor Medical Corp. · Mar 1989
BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER
K882330 · C.R. Bard, Inc. · Sep 1988
DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE
K875059 · Daig Corp. · Feb 1988
TEMPORARY PACEMAKER ELECTRODE
K872972 · Oscor Medical Corp. · Dec 1987
DEKNATEL TEMPORARY CARDIAC PACING WIRE
K873728 · Deknatel, Inc. · Nov 1987