Cleared Traditional

K781835 - PULSTRON MODEL 100

K781835 is an FDA 510(k) clearance for PULSTRON MODEL 100, manufactured by Micro-Rel. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K781835 · Micro-Rel · Cardiovascular device
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Dec 1978
Decision
52d
Days
Class 3
Risk

K781835 is an FDA 510(k) clearance for the PULSTRON MODEL 100. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Micro-Rel (Mchenry, US). The FDA issued a Cleared decision on December 21, 1978 after a review of 52 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 Micro-Rel devices

FDA 510(k) Submission Details - K781835

510(k) Number K781835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1978
Decision Date December 21, 1978
Days to Decision 52 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 125d · This submission: 52d
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 394
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K781835.
PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT
K782146 · Arco Medical Products Co. · Dec 1978
MICROLITH A MODEL 703
K782022 · Cardiac Pacemakers, Inc. · Dec 1978
MICROLITH A MODEL 803
K782023 · Cardiac Pacemakers, Inc. · Dec 1978
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