Cleared Traditional

K882429 - MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004

K882429 is an FDA 510(k) clearance for MODEL 255A PROGRAMMER III, manufactured by Tpl-Cordis, Inc.. The device is a Class 3 Cardiovascular device with product code KRG cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K882429 · Tpl-Cordis, Inc. · Cardiovascular device
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Jul 1988
Decision
38d
Days
Class 3
Risk

K882429 is an FDA 510(k) clearance for the MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004. Classified as Programmer, Pacemaker (product code KRG), Class III - Premarket Approval.

Submitted by Tpl-Cordis, Inc. (Englewood, US). The FDA issued a Cleared decision on July 22, 1988 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3700 - 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 Tpl-Cordis, Inc. devices

FDA 510(k) Submission Details - K882429

510(k) Number K882429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1988
Decision Date July 22, 1988
Days to Decision 38 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 125d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

KRG Device Classification - Class 3, Premarket Approval

Product Code KRG Programmer, Pacemaker
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3700
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 - KRG Programmer, Pacemaker

All 22
Devices cleared under the same product code (KRG) and FDA review panel - the closest regulatory comparables to K882429.
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