Cleared Traditional

K854195 - PROGRAMALITH III MODELS 238 & 239

K854195 is an FDA 510(k) clearance for PROGRAMALITH III MODELS 238 & 239, manufactured by Pacesetter Systems. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K854195 · Pacesetter Systems · Cardiovascular device
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Jan 1986
Decision
84d
Days
Class 3
Risk

K854195 is an FDA 510(k) clearance for the PROGRAMALITH III MODELS 238 & 239. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Pacesetter Systems (Sylmar, US). The FDA issued a Cleared decision on January 7, 1986 after a review of 84 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 Pacesetter Systems devices

FDA 510(k) Submission Details - K854195

510(k) Number K854195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1985
Decision Date January 07, 1986
Days to Decision 84 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
41d faster than avg
Panel avg: 125d · This submission: 84d
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 K854195.
IMPLANTABLE PROGRAMMABLE PULSE GENERATOR
K854560 · Telectronics, Inc. · Jan 1986
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
BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY
K854919 · Cook Pacemaker Corp. · Dec 1985
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