Cleared Traditional

K790432 - MICROLITH MODELS 505

Also marketed or referenced as:
605 507 607 703 803

K790432 is the FDA 510(k) clearance for MICROLITH MODELS 505 by Cardiac Pacemakers, Inc.. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K790432 · Cardiac Pacemakers, Inc. · Cardiovascular device
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Mar 1979
Decision
18d
Days
Class 3
Risk

K790432 is an FDA 510(k) clearance for the MICROLITH MODELS 505. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Cardiac Pacemakers, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 20, 1979 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 Cardiac Pacemakers, Inc. devices

Submission Details

510(k) Number K790432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1979
Decision Date March 20, 1979
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.

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 279
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K790432.
GENERATOR, 16 SERIES, MODIFIED TOP CAP
K790868 · Telectronics, Inc. · May 1979
OMNI-STANICOR-(THETA) MODEL 217
K790690 · Cordis Corp. · May 1979
PACEMAKERS WITHOUT SILASTIC COATING
K790764 · Telectronics, Inc. · Apr 1979
MINILITH AND MICROLITH
K790276 · Cardiac Pacemakers, Inc. · Feb 1979
PULSE GENERATOR, IMPLANTABLE CARDIAC
K782149 · Telectronics, Inc. · Feb 1979
BIPOLAR, STANICOR LAMBDA MODEL 236,235
K790014 · Cordis Corp. · Feb 1979