Cleared Traditional

K854919 - BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY

K854919 is an FDA 510(k) clearance for BIPOLAR CARDIAC PULSE GENERATOR WITH TE..., manufactured by Cook Pacemaker Corp.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K854919 · Cook Pacemaker Corp. · Cardiovascular device
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Dec 1985
Decision
10d
Days
Class 3
Risk

K854919 is an FDA 510(k) clearance for the BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Cook Pacemaker Corp. (Leechburg, US). The FDA issued a Cleared decision on December 19, 1985 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3610 - 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: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook Pacemaker Corp. devices

FDA 510(k) Submission Details - K854919

510(k) Number K854919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1985
Decision Date December 19, 1985
Days to Decision 10 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
115d faster than avg
Panel avg: 125d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

DXY Device Classification - Class 3, Premarket Approval

Product Code DXY Implantable Pacemaker Pulse-generator
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3610
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - DXY Implantable Pacemaker Pulse-generator

All 393
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K854919.
CORDIS MULTICOR ST, MODEL 350A
K851968 · Cordis Corp. · Jan 1986
ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER
K852641 · Sorin Biomedica, Fiat, USA, Inc. · Jan 1986
PROGRAMALITH III MODELS 238 & 239
K854195 · Pacesetter Systems · Jan 1986
SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM
K851365 · Sorin Biomedica, Fiat, USA, Inc. · Dec 1985
COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS
K854132 · Cook Pacemaker Corp. · Dec 1985
MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE
K854214 · Cordis Corp. · Dec 1985