Cleared Traditional

EPR-200 PROGRAMMER MODEL 010 (K800376) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K800376 · Biotronik Sales, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1980
Decision
60d
Days
Class 3
Risk

K800376 is an FDA 510(k) clearance for the EPR-200 PROGRAMMER MODEL 010. Classified as Programmer, Pacemaker (product code KRG), Class III - Premarket Approval.

Submitted by Biotronik Sales, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 21, 1980 after a review of 60 days - a notably fast clearance 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 Biotronik Sales, Inc. devices

Submission Details

510(k) Number K800376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1980
Decision Date April 21, 1980
Days to Decision 60 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 125d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 8
Devices cleared under the same product code (KRG) and FDA review panel - the closest regulatory comparables to K800376.
MODEL 2331T PATIENT PROGRAMMER
K880738 · Medtronic Vascular · Nov 1988
INTERMEDICS PROGRAMMER, MODEL 522-03
K812813 · Intermedics, Inc. · Oct 1981
CORDIS PACEMAKER PROGRAMMERS 255A & 256A
K810552 · Cordis Corp. · Mar 1981
OMNICOR PROGRAMMER MODEL 222C
K791419 · Cordis Corp. · Nov 1979
PACEMAKER PROGRAMMER
K790220 · Intermedics, Inc. · Jul 1979
RATE PROGRAMMER MODEL 520
K780175 · Intermedics, Inc. · Apr 1978