Cleared Traditional

MICROPULSE 22U (K780091) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K780091 · Edwards Pacemaker Systems · Cardiovascular device
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Jan 1978
Decision
14d
Days
Class 3
Risk

K780091 is an FDA 510(k) clearance for the MICROPULSE 22U. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Edwards Pacemaker Systems (Mchenry, US). The FDA issued a Cleared decision on January 30, 1978 after a review of 14 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 Edwards Pacemaker Systems devices

Submission Details

510(k) Number K780091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1978
Decision Date January 30, 1978
Days to Decision 14 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 125d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 135
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K780091.
GENERATORS, ATRIAL INHIBITED PULSE
K780327 · Medtronic Vascular · May 1978
PACEMAKER, MODEL 252, C-MOS
K780437 · Intermedics, Inc. · Apr 1978
CARDIAC PACER, MODEL 208
K780066 · Cordis Corp. · Jan 1978
PULSE GENERATORS, MODELS 5972/5973
K780061 · Medtronic Vascular · Jan 1978
PULSE GENERATORS
K772357 · Medtronic Vascular · Jan 1978
XYREL-RA MODELS 5994/5995
K771770 · Medtronic Vascular · Jan 1978