# K101685: IP-SET

- Pathway: 510(k) (Traditional)
- Applicant: Integral Process Sas
- Decided: Jul 1, 2010 after 15 days
- Product code: DRX (Electrode, Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2360
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K944260 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944260: Ecg Electrode, Msb, Ltd. (1995) Summary page 1.
- K944497: Unilect, Monitab and Biotrace-HR, Msb, Ltd. (1996) Summary page 1.
- K003804: Sensi-Prema Neonatal Ecg Electrodes, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801, Niko Medical Products (2001) Summary page 1.
- K011564: Neolead, Neotech Products, Inc. (2002) Summary page 1.

## Recalls of this device
- Mar 15, 2022 · Class II · Z-0936-2022: Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to with
- Mar 15, 2022 · Class II · Z-0937-2022: Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to with
- Mar 15, 2022 · Class II · Z-0938-2022: Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to with
- Mar 15, 2022 · Class II · Z-0940-2022: Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to with
- Mar 15, 2022 · Class II · Z-0935-2022: Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to with
- Mar 15, 2022 · Class II · Z-0939-2022: Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to with

## Indications for use
ECG pre-wired harnessed sets of electrodes for short and long term use; for adults, pediatrics and neonates. By design and manufacturing process, the lP-SET® ECG electrodes are of multidisciplinary use, and the unit choice is performed by the Physician, in function of the desired application. As per the reference chart: IP-Set® P/N Suggested Application X Rays Basic (B)/ Combined (C) Combination 50502-US Diagnostic . No C 50500-US + 50503-US 50505&US Diagnostic No C 50501-US + 50504-US 50506-US Diagnostic No, C 50500-US + 50510O-US 50507-US Diagnostic No B 50510-US () Used only in conjunction with No B PIN 50500-US for PIN 50506-US 50600-US Coronary/X Rays Yes B 50601-US Coronary/X Rays Yes B 50603-US CoronarylX Rays Yes B 50604-US CoronarylX Rays Yes B 50602-US CoronarylX Rays Yes C 50600-US + 50603-US 50605-US CoronarylX Rays Yes C 50601-US + 50604-US 50500-US Monitoring No B 50501-US Monitoring No B 50503-US Monitoring No B 50504-US Monitoring No B 50400-US Pediatrics Yes B 50401-US Neonatal Yes B Nota: Ref# 50510-US is used for manufacturing only, and is always marketed in conjunction with ref # 50500-US under ref # 50506-US

Source page: https://510kreport.com/device/K101685
Methodology: https://510kreport.com/methodology