Cleared Traditional

K860036 - EDP-20 PACEMAKER

K860036 is an FDA 510(k) clearance for EDP-20 PACEMAKER, manufactured by Biotronik Sales, Inc.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 371-day FDA review.

K860036 · Biotronik Sales, Inc. · Cardiovascular device
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Jan 1987
Decision
371d
Days
Class 3
Risk

K860036 is an FDA 510(k) clearance for the EDP-20 PACEMAKER. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Biotronik Sales, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on January 12, 1987 after a review of 371 days - an unusually long review period, suggesting complex equivalence evaluation.

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 Biotronik Sales, Inc. devices

FDA 510(k) Submission Details - K860036

510(k) Number K860036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1986
Decision Date January 12, 1987
Days to Decision 371 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
246d slower than avg
Panel avg: 125d · This submission: 371d
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 353
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K860036.
ASTRA T2, T4 AND T6
K865013 · Cardiac Pacemakers, Inc. · Feb 1987
MULTILITH 3 MODELS 1350, 3350, 1370, 3370
K863898 · Ela Medical, Inc. · Feb 1987
DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS
K862226 · Pacesetter Systems · Feb 1987
MODIFIED CIRCUIT BURN-IN PROCESS IMPLANTABLE PULSE
K862459 · Medtronic Vascular · Jan 1987
TRIOS-M VS-1 PULSE GENERATOR
K863878 · Biotronik Sales, Inc. · Dec 1986
NEOS-M VS-1 PULSE GENERATOR
K863879 · Biotronik Sales, Inc. · Dec 1986