Cleared Traditional

K011980 - ADAPTER

K011980 is the FDA 510(k) clearance for ADAPTER by Pace Medical. It is a Class 2 Cardiovascular device (product code DTE) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K011980 · Pace Medical · Cardiovascular device
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Sep 2001
Decision
79d
Days
Class 2
Risk

K011980 is an FDA 510(k) clearance for the ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825. Classified as Pulse-generator, Pacemaker, External (product code DTE), Class II - Special Controls.

Submitted by Pace Medical (Waltham, US). The FDA issued a Cleared decision on September 12, 2001 after a review of 79 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.

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Submission Details

510(k) Number K011980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2001
Decision Date September 12, 2001
Days to Decision 79 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 125d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 26
Devices cleared under the same product code (DTE) and FDA review panel - the closest regulatory comparables to K011980.
Medtronic Model 5392 External Pulse Generator (EPG)
K150246 · Medtronic, Inc. · Feb 2015
MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)
K132924 · Medtronic, Inc. · Oct 2013
ERA 3000 PACING SYSTEM ANALYZER
K042708 · Biotronik, Inc. · Oct 2004
MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL
K971474 · Medtronic Vascular · Jul 1997
ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
K964190 · Biotronik, Inc. · Jul 1997
MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR
K910237 · Medtronic Vascular · Feb 1991