Cleared Traditional

K914458 - ESCORT 300A SERIES DEFIBRILLATOR/PACER ...

K914458 is an FDA 510(k) clearance for ESCORT 300A SERIES DEFIBRILLATOR/PACER ..., manufactured by Medical Data Electronics. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K914458 · Medical Data Electronics · Cardiovascular device
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Dec 1991
Decision
63d
Days
Class 2
Risk

K914458 is an FDA 510(k) clearance for the ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Medical Data Electronics (Arleta, US). The FDA issued a Cleared decision on December 9, 1991 after a review of 63 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 Medical Data Electronics devices

FDA 510(k) Submission Details - K914458

510(k) Number K914458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1991
Decision Date December 09, 1991
Days to Decision 63 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
62d faster than avg
Panel avg: 125d · This submission: 63d
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 K914458.
MODEL #125 CHILD STIMULATION PADS
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K920086 · Cardiotronics, Inc. · Feb 1992
TEC-8251A DEFIBRILLATOR MONITOR, MODIFICATION
K914971 · Nihon Kohden America, Inc. · 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