Cleared Traditional

K860573 - IMPLANT PROG PULSE GENERATOR

K860573 is an FDA 510(k) clearance for IMPLANT PROG PULSE GENERATOR, 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 103-day FDA review.

K860573 · Telectronics, Inc. · Cardiovascular device
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May 1986
Decision
103d
Days
Class 3
Risk

K860573 is an FDA 510(k) clearance for the IMPLANT PROG PULSE GENERATOR, UNIPOLAR & BIPOLAR. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Telectronics, Inc. (Suffield, US). The FDA issued a Cleared decision on May 28, 1986 after a review of 103 days - within the typical 510(k) review window.

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 - K860573

510(k) Number K860573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1986
Decision Date May 28, 1986
Days to Decision 103 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
22d faster than avg
Panel avg: 125d · This submission: 103d
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 K860573.
MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN
K862037 · Medtronic Vascular · Jun 1986
MODIFY LABEL/SPECTRAX S & SX IMPLANT PULSE GENER
K862038 · Medtronic Vascular · Jun 1986
MODIFIED LABEL FOR/SPECTRAX SXT IMPLANT. PULSE GEN
K862071 · Medtronic Vascular · Jun 1986
SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS
K861559 · Cook Pacemaker Corp. · May 1986
PROGRAMALITH III PULSE GENERATOR
K861140 · Pacesetter Systems · May 1986
UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762
K852973 · Ela Medical, Inc. · Mar 1986