Cleared Traditional

K862226 - DIALOG MODELS 748

K862226 is the FDA 510(k) clearance for DIALOG MODELS 748 by Pacesetter Systems. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K862226 · Pacesetter Systems · Cardiovascular device
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Feb 1987
Decision
237d
Days
Class 3
Risk

K862226 is an FDA 510(k) clearance for the DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS. 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 February 3, 1987 after a review of 237 days - an extended review 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 K862226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1986
Decision Date February 03, 1987
Days to Decision 237 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
112d slower than avg
Panel avg: 125d · This submission: 237d
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 K862226.
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
K871861 · Telectronics, Inc. · Jun 1987
ASTRA T2, T4 AND T6
K865013 · Cardiac Pacemakers, Inc. · Feb 1987
MULTILITH 3 MODELS 1350, 3350, 1370, 3370
K863898 · Ela Medical, Inc. · Feb 1987
EDP-20 PACEMAKER
K860036 · Biotronik Sales, Inc. · Jan 1987
MODIFIED CIRCUIT BURN-IN PROCESS IMPLANTABLE PULSE
K862459 · Medtronic Vascular · Jan 1987
TRIOS-M VS-1 PULSE GENERATOR
K863878 · Biotronik Sales, Inc. · Dec 1986