Cleared Traditional

K781208 - GENERATORS, PULSE, MODELS 5988/5989

K781208 is an FDA 510(k) clearance for GENERATORS, manufactured by Medtronic Vascular. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K781208 · Medtronic Vascular · Cardiovascular device
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Oct 1978
Decision
81d
Days
Class 3
Risk

K781208 is an FDA 510(k) clearance for the GENERATORS, PULSE, MODELS 5988/5989. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on October 3, 1978 after a review of 81 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 Medtronic Vascular devices

FDA 510(k) Submission Details - K781208

510(k) Number K781208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1978
Decision Date October 03, 1978
Days to Decision 81 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
44d faster than avg
Panel avg: 125d · This submission: 81d
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 K781208.
PACEMAKER, MODEL 229-01
K781738 · Intermedics, Inc. · Dec 1978
GENERATOR, PULSE, SORIN MODEL DL-1
K780897 · Bentley Laboratories, Inc. · Dec 1978
ARCOBIOLITH PACEMAKER MODEL
K780776 · Arco Medical Products Co. · Oct 1978
GENERATOR, PULSE, MODEL 5997
K781252 · Medtronic Vascular · Oct 1978
PACEMAKER, MODEL 225 & 227
K772226 · Intermedics, Inc. · Sep 1978
GENERATOR, PULSE, MODEL 160B
K780940 · Telectronics, Inc. · Sep 1978