Cleared Traditional

K811638 - DATASCOPE INTERNAL DEFIBRILLATOR PADDLES

K811638 is an FDA 510(k) clearance for DATASCOPE INTERNAL DEFIBRILLATOR PADDLES, 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 30-day FDA review.

K811638 · Datascope Corp. · Cardiovascular device
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Jul 1981
Decision
30d
Days
Class 2
Risk

K811638 is an FDA 510(k) clearance for the DATASCOPE INTERNAL DEFIBRILLATOR PADDLES. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Datascope Corp. (Mchenry, US). The FDA issued a Cleared decision on July 10, 1981 after a review of 30 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 - K811638

510(k) Number K811638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1981
Decision Date July 10, 1981
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
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
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