Cleared Traditional

K890547 - SIEMENS ELEMA MODELS 4025 AND 4026 ADAP...

K890547 is the FDA 510(k) clearance for SIEMENS ELEMA MODELS 4025 AND 4026 ADAP... by Pacesetter Systems. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K890547 · Pacesetter Systems · Cardiovascular device
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Mar 1989
Decision
47d
Days
Class 3
Risk

K890547 is an FDA 510(k) clearance for the SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Pacesetter Systems (Sylmar, US). The FDA issued a Cleared decision on March 22, 1989 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - 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 K890547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1989
Decision Date March 22, 1989
Days to Decision 47 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
78d faster than avg
Panel avg: 125d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DTB Permanent Pacemaker Electrode
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3680
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 - DTB Permanent Pacemaker Electrode

All 364
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K890547.
HEPARIN BONDING FOR CATHETERS
K884697 · Daig Corp. · Apr 1989
MODELS 432-03 & 433-03 IMPLANTABLE PACING LEADS
K890411 · Intermedics, Inc. · Mar 1989
MODELS 430-07 & 431-07 IMPLANTABLE PACING LEADS
K890412 · Intermedics, Inc. · Mar 1989
VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)
K890350 · Telectronics, Inc. · Feb 1989
MODEL 6208,6209,6210,6211,6212,6214 (PLI'S)
K890045 · Medtronic Vascular · Jan 1989
MEDTRONIC MODEL 4058 PACING LEAD
K883743 · Medtronic Vascular · Jan 1989