Cleared Traditional

K854853 - NI-PACER 1

K854853 is an FDA 510(k) clearance for NI-PACER 1, manufactured by Associated Medical Devices, Inc.. The device is a Class 2 Cardiovascular device with product code DRO cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K854853 · Associated Medical Devices, Inc. · Cardiovascular device
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Feb 1986
Decision
71d
Days
Class 2
Risk

K854853 is an FDA 510(k) clearance for the NI-PACER 1. Classified as Pacemaker, Cardiac, External Transcutaneous (non-invasive) (product code DRO), Class II - Special Controls.

Submitted by Associated Medical Devices, Inc. (Carlsbad, US). The FDA issued a Cleared decision on February 14, 1986 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5550 - 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 Associated Medical Devices, Inc. devices

FDA 510(k) Submission Details - K854853

510(k) Number K854853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1985
Decision Date February 14, 1986
Days to Decision 71 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 125d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRO Device Classification - Class 2, Special Controls

Product Code DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5550
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 - DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)

All 57
Devices cleared under the same product code (DRO) and FDA review panel - the closest regulatory comparables to K854853.
MEDTRONIC MODEL 5455 DISPOSABLE SURGICAL CABLE
K863547 · Medtronic Vascular · Oct 1986
ALTERNATE SIZE E-Z-PACE ELECTRODE
K862298 · Medtronic Vascular · Jul 1986
AMI CARDIO-PAD
K860283 · Andover Medical, Inc. · Mar 1986
AMENDMENT LIFEPAK 8, NPN 052
K854117 · Physio-Control Corp. · Jan 1986
LIFEPAK 8 MODIFICATION
K853732 · Physio-Control Corp. · Dec 1985
EMERGIPACE - EXTERNAL PACEMAKER
K850812 · Life Science Instrumentation, Inc. · Nov 1985