Cleared Traditional

K854790 - CERYX PACEMAKER MODELS 114

K854790 is an FDA 510(k) clearance for CERYX PACEMAKER MODELS 114, manufactured by Vitatron Medical BV. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K854790 · Vitatron Medical BV · Cardiovascular device
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Aug 1986
Decision
272d
Days
Class 3
Risk

K854790 is an FDA 510(k) clearance for the CERYX PACEMAKER MODELS 114, 314 & 614. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Vitatron Medical BV (Minneapolis, US). The FDA issued a Cleared decision on August 28, 1986 after a review of 272 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 Vitatron Medical BV devices

FDA 510(k) Submission Details - K854790

510(k) Number K854790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1985
Decision Date August 28, 1986
Days to Decision 272 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
147d slower than avg
Panel avg: 125d · This submission: 272d
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 388
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K854790.
MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER)
K863582 · Cook Pacemaker Corp. · Oct 1986
MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE
K863418 · Intermedics, Inc. · Sep 1986
ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN.
K862974 · Medtronic Vascular · Sep 1986
NEOS VS-1, PULSE GENERATOR
K860921 · Biotronik Sales, Inc. · Aug 1986
MIKROS, MIKROS VS-1, PULSE GENERATOR
K860922 · Biotronik Sales, Inc. · Aug 1986
ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR
K860585 · Cardiac Pacemakers, Inc. · Jul 1986