Cleared Traditional

K892528 - FIVE-YEAR STERILE PACKAGING SHELF LIFE

K892528 is an FDA 510(k) clearance for FIVE-YEAR STERILE PACKAGING SHELF LIFE, manufactured by Daig Corp.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 282-day FDA review.

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

FDA 510(k) Submission Details - K892528

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 125d · This submission: 282d
Pathway characteristics
Predicate-based equivalence.

DTB Device Classification - Class 3, Premarket Approval

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 423
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K892528.
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
MODIFIED J-STIFFENER WIRE MATERIAL IN LEAD LINES
K897067 · Telectronics Pacing Systems, Inc. · Feb 1990
ENDOCARDIAL SCREW-IN LEAD MODEL 1020T
K895447 · Pacesetter Systems · Dec 1989
MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS
K896443 · Possis Medical, Inc. · Dec 1989
NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI
K893041 · Telectronics Pacing Systems, Inc. · Nov 1989