Cleared Traditional

K820774 - IMPLANTABLE

K820774 is an FDA 510(k) clearance for IMPLANTABLE, 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 17-day FDA review.

K820774 · Biotronik Sales, Inc. · Cardiovascular device
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Apr 1982
Decision
17d
Days
Class 3
Risk

K820774 is an FDA 510(k) clearance for the IMPLANTABLE, MULTIPROGRAMMABLE. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Biotronik Sales, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 9, 1982 after a review of 17 days - a notably fast clearance 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 Biotronik Sales, Inc. devices

FDA 510(k) Submission Details - K820774

510(k) Number K820774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1982
Decision Date April 09, 1982
Days to Decision 17 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
108d faster than avg
Panel avg: 125d · This submission: 17d
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 K820774.
PULSE GENERATOR
K821073 · Biotronik Sales, Inc. · May 1982
COOK #326T PROGRAM/TELEMETRY BIPOLAR
K821147 · Cook Pacemaker Corp. · May 1982
PULSE GENERATOR 678 B
K820657 · Siemens Elema AB · Apr 1982
QUANTUM MODELS 253-09, 254-09 254-10
K820853 · Intermedics, Inc. · Apr 1982
MULTICOR (GAMMA) 402 CARDIAC PACER
K820356 · Cordis Corp. · Mar 1982
COMMAND ULTRA I
K820231 · Cardiac Pacemakers, Inc. · Mar 1982