Cleared Traditional

K844447 - M/D4 W/CHARGER (CARDIOPAC 3M11)

K844447 is an FDA 510(k) clearance for M/D4 W/CHARGER (CARDIOPAC 3M11), manufactured by Datascope Corp.. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K844447 · Datascope Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1985
Decision
59d
Days
Class 2
Risk

K844447 is an FDA 510(k) clearance for the M/D4 W/CHARGER (CARDIOPAC 3M11). Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on January 14, 1985 after a review of 59 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 Datascope Corp. devices

FDA 510(k) Submission Details - K844447

510(k) Number K844447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1984
Decision Date January 14, 1985
Days to Decision 59 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 125d · This submission: 59d
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 113
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K844447.
PORTABLE DEFIBRILLATOR/MONITOR ED 425
K851092 · Honeywell, Inc. · Apr 1985
MODELS 43100A, 43110A & 43120A DEFIBRILLATOR/MONIT
K844740 · Hewlett-Packard Co. · Feb 1985
CARDIOPAC DEFIBRILLATOR 444
K844103 · Birtcher Corp. · Jan 1985
LS-260G MONITOR/RECORDER & DEFIBILLATOR
K843396 · Life Science Instrumentation, Inc. · Oct 1984
LIFEPAK 8
K842624 · Physio-Control Corp. · Oct 1984
LIFEPAK 200
K843229 · Physio-Control Corp. · Oct 1984