510(k) Report

510(k) · Cleared

Cleared

K-Defib/Pace Adult Electrode, Model KDP-85

K012404510(k) TraditionalCleared Oct 12, 200174-day reviewClass II21 CFR 870.5550

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Katecho, Inc. · DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

Cleared on Oct 12, 2001 after a 74-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Oct 12, 2001
Review
74 days
Class
Class II
Product code
DRO
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K012404Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DRO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All DRO devices

DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRO

FDA has decided no DRO device since 2007.

Median 510(k) review, days · DRO

Too few DRO 510(k)s in any year since 2007 to give a median.

Recalls per year · DRO

12in 2020

2010: 12014: 4, 4 Class I2020: 12
2007high 12 (2020) · low 0 (2007)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · DRO

2in 2025

2007: 72008: 52009: 32010: 72011: 32012: 82013: 112014: 22015: 412016: 492017: 152018: 642019: 932020: 192021: 222023: 62024: 42025: 2
2007high 93 (2019) · low 0 (2022)2025

MAUDE reports naming product code DRO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—07
20080—05
20090—03
20100—17
20110—03
20120—08
20130—011
20140—4 (4)2
20150—041
20160—049
20170—015
20180—064
20190—093
20200—1219
20210—022
20220—00
20230—06
20240—04
20250—02
20260—0—

What is it indicated for?

The Katecho external electrodes are indicated for use in external pacing, defibrillation, cardioversion and monitoring applications as a non-sterile, disposable device for single patient use only. The KDP-85 Electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient’s skin. The electrode is intended for use on adult patients. When a patient requires…

Read the full statement (113 words)

The Katecho external electrodes are indicated for use in external pacing, defibrillation, cardioversion and monitoring applications as a non-sterile, disposable device for single patient use only. The KDP-85 Electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient’s skin. The electrode is intended for use on adult patients.

When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum).

The Katecho KDP-85 Defib/Pace Electrodes are designed for, and to be used, with Agilent Technologies defibrillation devices.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Katecho, Inc.

26 FDA decisions under this applicant name. See the company

  • K010543KM-30 Tens ElectrodeKatecho, Inc. · 2001
  • K003228K-Defib/Pace Multifuction Pediatric Electrode, Model KDP-70AKatecho, Inc. · 20001 recall
  • K002806K-Defib/Pace, Model KDP-60AKatecho, Inc. · 2000
  • K000870KM-10 Tens ElectrodeKatecho, Inc. · 2000
  • K993745K-Defib/Pace Adult Electrode, Model KDP-80Katecho, Inc. · 2000

Recent decisions in DRO

The DRO category page

  • K012218Ludlow Gradient Edge Adult & Pediatric Multifunctional ElectrodesThe Ludlow Company LP · 20014 Class I recalls
  • K000660Escort II+ 400 Series (Escort Prism), Model 20400, 20401, 20403, Monitor, Models 20411, 20412, 20413Medical Data Electronics · 2000
  • K983196Padtak Pace/Defib/Cardiovert Monitoring Electrode (S)Tz Medical, Inc. · 19991 recall
  • K983232Padtak Pediatric Defib/Cardiovert/Pace/Monitor-Radiotransparent (2X2.25),Model 2602, Padtak Pediatric…Tz Medical, Inc. · 1999
  • K974034Portable Intensive Care UnitMedical Research Laboratories, Inc. · 19983 recalls

https://510kreport.com/device/K012404 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012404: K-Defib/Pace Adult Electrode, Model KDP-85.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012404

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Page last updated Nov 3, 2026