Cleared Traditional

K781738 - PACEMAKER

K781738 is an FDA 510(k) clearance for PACEMAKER, 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 51-day FDA review.

K781738 · Intermedics, Inc. · Cardiovascular device
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Dec 1978
Decision
51d
Days
Class 3
Risk

K781738 is an FDA 510(k) clearance for the PACEMAKER, MODEL 229-01. 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 December 7, 1978 after a review of 51 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 - K781738

510(k) Number K781738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1978
Decision Date December 07, 1978
Days to Decision 51 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
74d faster than avg
Panel avg: 125d · This submission: 51d
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 K781738.
ISOLATION SLEEVE, MODEL 346-01
K790101 · Intermedics, Inc. · Jan 1979
MICROLITH A MODEL 703
K782022 · Cardiac Pacemakers, Inc. · Dec 1978
MICROLITH A MODEL 803
K782023 · Cardiac Pacemakers, Inc. · Dec 1978
GENERATOR, PULSE, SORIN MODEL DL-1
K780897 · Bentley Laboratories, Inc. · Dec 1978
GENERATORS, PULSE, MODELS 5988/5989
K781208 · Medtronic Vascular · Oct 1978
GENERATOR, PULSE, MODEL 5997
K781252 · Medtronic Vascular · Oct 1978