510(k) · Cleared
Recalled · Class II · 2022IP-SET
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integral Process Sas · DRX Electrode, Electrocardiograph
Cleared on Jul 1, 2010 as substantially equivalent to K944260 (Msb, Ltd., 1995) and 3 other predicates after a 15-day review. Its family tree reaches back 1 generation to 1995. It has been recalled 6 times.
- Decided
- Jul 1, 2010
- Review
- 15 days
- Class
- Class II
- Product code
- DRX
- Recalls
- 6
- Predicates
- 4
Its longest line of descent runs back 1 generation to K944260 (1995). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK944260 Ecg ElectrodeMsb, Ltd. · 1995
- This deviceK101685 IP-SETIntegral Process Sas · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944260 | Ecg Electrode | Msb, Ltd. | 1995 | — |
| 0 (this device) | K101685 | IP-SET | Integral Process Sas | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRX? 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
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K944260 | Ecg ElectrodeSummary page 1…onality MSB Ltd. (UK) -1994 __________ Diagnostics K944260 IUnomedical USA - 2008 ECG Electrode - (0915M) Other Monitoring appl.… | 1995 |
| * | K944497 | Unilect, Monitab and Biotrace-HRSummary page 1…nostics K944260 IUnomedical USA - 2008 ECG Electrode - (0915M) Other Monitoring appl. K944497 UnileCtTM, Monitab and… | 1996 |
| * | K003804 | Sensi-Prema Neonatal Ecg Electrodes…Summary page 1…____ Biotrace-HR (1014M ) Manufacturing ________FNIKO Medical Products -2000 [Sensi-prerna neonatal ecg Ultrasonic welding j K003804 )Unomedical USA -2008 [electrodes - (45550) Electrode Com ponents _ _ _ _ _ _ _ _ _ _… | 2001 |
| * | K011564 | NeoleadSummary page 1…ctrode Com ponents _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Adhesive /hydrogel K011564 INeotech Products Inc. Neolead Ill Device Description: Set of dis… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 15, 2022 | Class II | Z-0936-2022 | Device Design | 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 withstand, without breakdown , an… |
| Mar 15, 2022 | Class II | Z-0937-2022 | Device Design | 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 withstand, without breakdown , an… |
| Mar 15, 2022 | Class II | Z-0938-2022 | Device Design | 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 withstand, without breakdown , an… |
| Mar 15, 2022 | Class II | Z-0940-2022 | Device Design | 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 withstand, without breakdown , an… |
| Mar 15, 2022 | Class II | Z-0935-2022 | Device Design | 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 withstand, without breakdown , an… |
| Mar 15, 2022 | Class II | Z-0939-2022 | Device Design | 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 withstand, without breakdown , an… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K944260.
How does its category compare?
All DRX devicesDRX Electrode, Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DRX
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · DRX
78in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRX
6in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRX
250in 2025
MAUDE reports naming product code DRX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 147 | 0 | 47 |
| 2008 | 3 | 17 | 0 | 15 |
| 2009 | 7 | 89 | 0 | 36 |
| 2010 | 5 | 78 | 4 | 48 |
| 2011 | 0 | — | 0 | 80 |
| 2012 | 0 | — | 0 | 41 |
| 2013 | 1 | — | 0 | 70 |
| 2014 | 1 | — | 0 | 27 |
| 2015 | 0 | — | 1 | 58 |
| 2016 | 0 | — | 0 | 37 |
| 2017 | 1 | — | 0 | 55 |
| 2018 | 0 | — | 0 | 43 |
| 2019 | 0 | — | 0 | 50 |
| 2020 | 0 | — | 5 | 53 |
| 2021 | 0 | — | 1 | 55 |
| 2022 | 0 | — | 6 | 61 |
| 2023 | 0 | — | 0 | 113 |
| 2024 | 0 | — | 0 | 61 |
| 2025 | 0 | — | 0 | 250 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (183 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101685 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101685: IP-SET.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101685
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026