Cleared Traditional

K880780 - HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG

K880780 is an FDA 510(k) clearance for HEARTSTART 2000 DEFIBRILLATOR TESTER, manufactured by First Medical Devices Corp.. The device is a Class 2 Cardiovascular device with product code DRL cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K880780 · First Medical Devices Corp. · Cardiovascular device
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May 1988
Decision
76d
Days
Class 2
Risk

K880780 is an FDA 510(k) clearance for the HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG. Classified as Tester, Defibrillator (product code DRL), Class II - Special Controls.

Submitted by First Medical Devices Corp. (Bellevue, US). The FDA issued a Cleared decision on May 12, 1988 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5325 - 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 First Medical Devices Corp. devices

FDA 510(k) Submission Details - K880780

510(k) Number K880780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1988
Decision Date May 12, 1988
Days to Decision 76 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 125d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRL Device Classification - Class 2, Special Controls

Product Code DRL Tester, Defibrillator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5325
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 - DRL Tester, Defibrillator

All 14
Devices cleared under the same product code (DRL) and FDA review panel - the closest regulatory comparables to K880780.
MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER
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K941404 · Hogan & Hartson · Jun 1994
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K904159 · Bio-Tek Instruments, Inc. · Mar 1991
DEFIBRILLATOR INTERAL PADDLE TEST LOAD
K790394 · Physio-Control Corp. · Mar 1979
CARDIAC CARE Q/C TEST KIT
K782033 · Instrumentation Laboratory CO · Dec 1978