Cleared Traditional

K914971 - TEC-8251A DEFIBRILLATOR MONITOR

K914971 is an FDA 510(k) clearance for TEC-8251A DEFIBRILLATOR MONITOR, manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K914971 · Nihon Kohden America, Inc. · Cardiovascular device
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Dec 1991
Decision
47d
Days
Class 2
Risk

K914971 is an FDA 510(k) clearance for the TEC-8251A DEFIBRILLATOR MONITOR, MODIFICATION. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on December 4, 1991 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5300 - 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 Nihon Kohden America, Inc. devices

FDA 510(k) Submission Details - K914971

510(k) Number K914971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1991
Decision Date December 04, 1991
Days to Decision 47 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 125d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDD Device Classification - Class 2, Special Controls

Product Code LDD Dc-defibrillator, Low-energy, (including Paddles)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5300
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 - LDD Dc-defibrillator, Low-energy, (including Paddles)

All 86
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K914971.
PEDIATRIC DISPOSABLE EXTERNAL DEFIBRILATION/ECG
K912966 · Physio-Control Corp. · Feb 1992
SHOCK-PATCH ADULT DEFIBRILLATION PADS
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ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION
K914458 · Medical Data Electronics · Dec 1991
MODEL #100 SHOCK-TRODE CHILD DEFIB PADS
K911455 · Cardiotronics, Inc. · Oct 1991
MODEL #110 STEALTH-TRODE CHILD DEFIB PADS
K911456 · Cardiotronics, Inc. · Oct 1991
MODEL #911 STEALTH MULTI PADS
K912621 · Cardiotronics, Inc. · Oct 1991