Cleared Traditional

K823878 - IMPLANTABLE PACEMAKER PULSE GEN

K823878 is the FDA 510(k) clearance for IMPLANTABLE PACEMAKER PULSE GEN by Pacesetter Systems. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K823878 · Pacesetter Systems · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1983
Decision
87d
Days
Class 3
Risk

K823878 is an FDA 510(k) clearance for the IMPLANTABLE PACEMAKER PULSE GEN, MODELS 241 & 242. 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 March 24, 1983 after a review of 87 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

Submission Details

510(k) Number K823878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1982
Decision Date March 24, 1983
Days to Decision 87 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
38d faster than avg
Panel avg: 125d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 339
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K823878.
COMMAND ULTRA II
K831216 · Cardiac Pacemakers, Inc. · Jul 1983
COMMAND ULTRA I
K831161 · Cardiac Pacemakers, Inc. · Jun 1983
NEDS-01 & EPR-500
K830862 · Biotronik Sales, Inc. · May 1983
IMPLANTABLE BIPOLAR CARDIAC PULSE GEN
K830390 · Telectronics, Inc. · Mar 1983
COMMAND ULTRA II
K830382 · Cardiac Pacemakers, Inc. · Mar 1983
UNILITH PULSE GENERATOR VVI #7542
K830401 · Ela Medical, Inc. · Mar 1983