Cleared Traditional

K801544 - PORTA-FIB LPD

K801544 is an FDA 510(k) clearance for PORTA-FIB LPD, manufactured by Narco Bio-Systems. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K801544 · Narco Bio-Systems · Cardiovascular device
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Jul 1980
Decision
7d
Days
Class 2
Risk

K801544 is an FDA 510(k) clearance for the PORTA-FIB LPD. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Narco Bio-Systems (Mchenry, US). The FDA issued a Cleared decision on July 14, 1980 after a review of 7 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 Narco Bio-Systems devices

FDA 510(k) Submission Details - K801544

510(k) Number K801544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1980
Decision Date July 14, 1980
Days to Decision 7 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 125d · This submission: 7d
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 116
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K801544.
DEFIBRILLATOR/MONITOR
K812317 · Hewlett-Packard Co. · Sep 1981
DATASCOPE INTERNAL DEFIBRILLATOR PADDLES
K811638 · Datascope Corp. · Jul 1981
PORTABLE, BATTERY OPERATED DEFIBRILLATOR
K810237 · Honeywell, Inc. · Feb 1981
DEFIBRILLATOR, MARK II
K781678 · Ipco Corp. · Dec 1978
PANTRIDGE MK III DEFIBRILLATOR/MONITOR
K780416 · Ipco Corp. · Apr 1978