Cleared Traditional

K800030 - IMPLANTABLE BIPOLAR CARDIAC PULSE GEN.

K800030 is an FDA 510(k) clearance for IMPLANTABLE BIPOLAR CARDIAC PULSE GEN., manufactured by Telectronics, Inc.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 4-day FDA review.

K800030 · Telectronics, Inc. · Cardiovascular device
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Jan 1980
Decision
4d
Days
Class 3
Risk

K800030 is an FDA 510(k) clearance for the IMPLANTABLE BIPOLAR CARDIAC PULSE GEN.. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Telectronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 11, 1980 after a review of 4 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 Telectronics, Inc. devices

FDA 510(k) Submission Details - K800030

510(k) Number K800030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1980
Decision Date January 11, 1980
Days to Decision 4 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
121d faster than avg
Panel avg: 125d · This submission: 4d
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 339
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K800030.
SORIN PULSE GENERATOR MODEL # LIT 214 H
K792565 · Bentley Laboratories, Inc. · Feb 1980
MICROTHIN-DI
K800026 · Cardiac Pacemakers, Inc. · Jan 1980
MICROTHIN-PI
K800027 · Cardiac Pacemakers, Inc. · Jan 1980
IMPLANTABLE PROGRAMMABLE UNIPOLAR
K792519 · Telectronics, Inc. · Dec 1979
MEDTRONIC MODELS 5984/5985
K791316 · Medtronic Vascular · Nov 1979
OMNI-STANICOR (THETA) MOD 237A
K791783 · Cordis Corp. · Oct 1979