Cleared Traditional

K844484 - HEWLETT PACKARDT HP 85 W/ VITATRON PH1 ...

K844484 is an FDA 510(k) clearance for HEWLETT PACKARDT HP 85 W/ VITATRON PH1 ..., 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 247-day FDA review.

K844484 · Vitatron Medical BV · Cardiovascular device
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Jul 1985
Decision
247d
Days
Class 3
Risk

K844484 is an FDA 510(k) clearance for the HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA. 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 July 24, 1985 after a review of 247 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 - K844484

510(k) Number K844484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1984
Decision Date July 24, 1985
Days to Decision 247 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
122d slower than avg
Panel avg: 125d · This submission: 247d
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 K844484.
PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580
K863045 · Cardiac Pacemakers, Inc. · Sep 1986
SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN
K860584 · Cardiac Pacemakers, Inc. · Jun 1986
DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37
K860546 · Pacesetter Systems · Apr 1986
TP 1
K844483 · Vitatron Medical BV · Apr 1985
CERYX6, 611, CERYX 3 311 & CERYX 1 111
K844485 · Vitatron Medical BV · Apr 1985
HANDHELD PACEMAKER PROGRAMMER & SOFTWAR
K842364 · Cardiac Pacemakers, Inc. · Sep 1984