Cleared Traditional

K844485 - CERYX6

K844485 is an FDA 510(k) clearance for CERYX6, manufactured by Vitatron Medical BV. The device is a Class 3 Cardiovascular device with product code KRG cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K844485 · Vitatron Medical BV · Cardiovascular device
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Apr 1985
Decision
151d
Days
Class 3
Risk

K844485 is an FDA 510(k) clearance for the CERYX6, 611, CERYX 3 311 & CERYX 1 111. Classified as Programmer, Pacemaker (product code KRG), Class III - Premarket Approval.

Submitted by Vitatron Medical BV (Dieren, NL). The FDA issued a Cleared decision on April 19, 1985 after a review of 151 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3700 - 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 - K844485

510(k) Number K844485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1984
Decision Date April 19, 1985
Days to Decision 151 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
26d slower than avg
Panel avg: 125d · This submission: 151d
Pathway characteristics
Predicate-based equivalence.

KRG Device Classification - Class 3, Premarket Approval

Product Code KRG Programmer, Pacemaker
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3700
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 - KRG Programmer, Pacemaker

All 21
Devices cleared under the same product code (KRG) and FDA review panel - the closest regulatory comparables to K844485.
DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37
K860546 · Pacesetter Systems · Apr 1986
HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA
K844484 · Vitatron Medical BV · Jul 1985
TP 1
K844483 · Vitatron Medical BV · Apr 1985
HANDHELD PACEMAKER PROGRAMMER & SOFTWAR
K842364 · Cardiac Pacemakers, Inc. · Sep 1984
PACEMAKER PROGRAMMER 2030
K820230 · Cardiac Pacemakers, Inc. · Mar 1982
INTERMEDICS PROGRAMMER, MODEL 522-03
K812813 · Intermedics, Inc. · Oct 1981