Cleared Traditional

FIVE-YEAR STERILE PACKAGING SHELF LIFE (K892528) - FDA 510(k) Clearance

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

K892528 · Daig Corp. · Cardiovascular device
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Jan 1990
Decision
282d
Days
Class 3
Risk

K892528 is an FDA 510(k) clearance for the FIVE-YEAR STERILE PACKAGING SHELF LIFE. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Daig Corp. (Minnetonka, US). The FDA issued a Cleared decision on January 18, 1990 after a review of 282 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - 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 Daig Corp. devices

Submission Details

510(k) Number K892528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1989
Decision Date January 18, 1990
Days to Decision 282 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 125d · This submission: 282d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DTB Permanent Pacemaker Electrode
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3680
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 - DTB Permanent Pacemaker Electrode

All 187
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K892528.
MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1
K900984 · Medtronic Vascular · May 1990
MEDTRONIC IMPLANTABLE PACING LEADS W/IS-1 CONN.
K896313 · Medtronic Vascular · Mar 1990
PERMANENT AND TEMP. PACEMAKER ELECTRODE & LEAD ADA
K895136 · Medtronic Vascular · Feb 1990
IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR
K894040 · Medtronic Vascular · Jul 1989
MEDTRONIC MODEL 5866-45 SIZING SLEEVE
K890644 · Medtronic Vascular · May 1989
ALTERNATE PACKAGING CONFIGURATION FOR PACING LEADS
K890527 · Medtronic Vascular · Apr 1989