Cleared Traditional

K915364 - CHRONOCOR VI MODEL 5012

K915364 is an FDA 510(k) clearance for CHRONOCOR VI MODEL 5012, manufactured by Seamed Corp.. The device is a Class 2 Cardiovascular device with product code DTE cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K915364 · Seamed Corp. · Cardiovascular device
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Feb 1992
Decision
72d
Days
Class 2
Risk

K915364 is an FDA 510(k) clearance for the CHRONOCOR VI MODEL 5012. Classified as Pulse-generator, Pacemaker, External (product code DTE), Class II - Special Controls.

Submitted by Seamed Corp. (Bothell, US). The FDA issued a Cleared decision on February 7, 1992 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3600 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Seamed Corp. devices

FDA 510(k) Submission Details - K915364

510(k) Number K915364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1991
Decision Date February 07, 1992
Days to Decision 72 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 125d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTE Device Classification - Class 2, Special Controls

Product Code DTE Pulse-generator, Pacemaker, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3600
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DTE Pulse-generator, Pacemaker, External

All 51
Devices cleared under the same product code (DTE) and FDA review panel - the closest regulatory comparables to K915364.
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K912507 · Seamed Corp. · Sep 1991
MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR
K910237 · Medtronic Vascular · Feb 1991