Cleared Traditional

K863582 - MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER)

K863582 is an FDA 510(k) clearance for MODEL 725TH HANDHELD TRANSCEIVER (PROGR..., manufactured by Cook Pacemaker Corp.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K863582 · Cook Pacemaker Corp. · Cardiovascular device
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Oct 1986
Decision
23d
Days
Class 3
Risk

K863582 is an FDA 510(k) clearance for the MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER). Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Cook Pacemaker Corp. (Leechburg, US). The FDA issued a Cleared decision on October 8, 1986 after a review of 23 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 Cook Pacemaker Corp. devices

FDA 510(k) Submission Details - K863582

510(k) Number K863582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1986
Decision Date October 08, 1986
Days to Decision 23 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
102d faster than avg
Panel avg: 125d · This submission: 23d
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 393
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K863582.
TRIOS-M VS-1 PULSE GENERATOR
K863878 · Biotronik Sales, Inc. · Dec 1986
NEOS-M VS-1 PULSE GENERATOR
K863879 · Biotronik Sales, Inc. · Dec 1986
CORDIS MULTICOR II MODEL 402D PACER
K863417 · Cordis Corp. · Oct 1986
MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE
K863418 · Intermedics, Inc. · Sep 1986
ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN.
K862974 · Medtronic Vascular · Sep 1986
CERYX PACEMAKER MODELS 114, 314 & 614
K854790 · Vitatron Medical BV · Aug 1986