Cleared Traditional

K771626 - PACEMAKER MODEL 251

K771626 is an FDA 510(k) clearance for PACEMAKER MODEL 251, manufactured by Intermedics, Inc.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K771626 · Intermedics, Inc. · Cardiovascular device
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Sep 1977
Decision
18d
Days
Class 3
Risk

K771626 is an FDA 510(k) clearance for the PACEMAKER MODEL 251. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1977 after a review of 18 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 Intermedics, Inc. devices

FDA 510(k) Submission Details - K771626

510(k) Number K771626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1977
Decision Date September 12, 1977
Days to Decision 18 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
107d faster than avg
Panel avg: 125d · This submission: 18d
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 354
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K771626.
PULSE GENERATOR, A-V SEQ.
K772202 · Medtronic Vascular · Dec 1977
CARDIAC PULSE GENERATOR, MODEL 150L
K772026 · Telectronics, Inc. · Nov 1977
BIPOLAR PACEMAKER MODEL 224
K772057 · Intermedics, Inc. · Nov 1977
IMPLANTED PACEMAKER PLUSE GENERATOR
K771670 · Telectronics, Inc. · Sep 1977
GENERATOR, PULSE, UNIPOLAR, #508
K770880 · Cardiac Pacemakers, Inc. · Jun 1977
GENERATOR, PULSE, BIPOLAR 3608
K770881 · Cardiac Pacemakers, Inc. · Jun 1977