PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS— 510(k) K014209

Name: FDA 510(k) clearance K014209
Creator: U.S. Food and Drug Administration
Published: 2002-01-18

Substantially Equivalent

Padpro, LLC

FDA 510(k) clearance K014209 for PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS, Substantially Equivalent on 2002-01-18. Applicant: Padpro, LLC. Device class: 3.

Clearance details

Applicant: Padpro, LLC
Product code: Code MKJ
Device class: Class 3
Regulation: 21 CFR 870.5310
Advisory panel: Cardiovascular
Date received: 2001-12-21
Decision date: 2002-01-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Deer Field, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MKJ

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K143714 — Powerheart G5 AED2015-05-04
K150055 — OneStep Pediatric CPR Multi-Function Electrode2015-05-02
K150198 — CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel2015-05-02
K142709 — samaritan PAD 450P2015-03-27
K133659 — HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING2015-01-23

More clearances from Padpro, LLC

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K020743 — PADPRO, MODEL 25022002-05-28
K020203 — PADPRO MODEL #25162002-05-08
K020288 — PADPRO, MODEL 26032002-02-27
K003548 — PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS2001-09-04

Adverse events under product code MKJ

product code MKJ

Death: 961
Injury: 1,070
Malfunction: 90,719
Other: 8
Total: 92,758

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K014209

K-number listed on FDA's recall record

Z-0454-2015 — ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.Class I·Terminated·ConMed Corporation·20141106
Z-0455-2015 — ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTORClass I·Terminated·ConMed Corporation·20141106
Z-0456-2015 — ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTORClass I·Terminated·ConMed Corporation·20141106
Z-1317-2013 — PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult Radiotransparent Multifunction Electrodes with Carbon Leadwires and Medtronic(R) Connector are intended to be used in external pacing, defibrillation and monitoring applicationsClass II·Terminated·ConMed Corporation·20130503

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K014209.

Data sourced from openFDA. This site is unofficial and independent of the FDA.