Cleared Traditional

K781090 - GENERATOR

K781090 is an FDA 510(k) clearance for 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 66-day FDA review.

K781090 · Telectronics, Inc. · Cardiovascular device
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Sep 1978
Decision
66d
Days
Class 3
Risk

K781090 is an FDA 510(k) clearance for the GENERATOR, CARDIAC PULSE, 250B. 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 September 7, 1978 after a review of 66 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 - K781090

510(k) Number K781090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1978
Decision Date September 07, 1978
Days to Decision 66 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
59d faster than avg
Panel avg: 125d · This submission: 66d
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 K781090.
PACEMAKER, MODEL 225 & 227
K772226 · Intermedics, Inc. · Sep 1978
GENERATOR, PULSE, MODEL 160B
K780940 · Telectronics, Inc. · Sep 1978
GENERATORS: UDL-201B, BDL-201B, MDL-201B
K781424 · Pacesetter Systems · Sep 1978
CARDIAL PULSE GENERATORS
K781426 · Telectronics, Inc. · Sep 1978
GENERATOR, PULSE, DEMAND, MODEL 5996
K780741 · Medtronic Vascular · Jul 1978
GENERATOR, PULSE MODELS 5920/5921
K780809 · Medtronic Vascular · Jul 1978