510(k) · Cleared
ClearedECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integral Process Sas · DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Cleared on Aug 16, 2017 as substantially equivalent to K120010 (Shenzhen Med-Link Electronics Tech Co., Ltd., 2012) and 2 other predicates after a 320-day review. Its family tree reaches back 3 generations to 2000. 2 later devices descend from it.
- Decided
- Aug 16, 2017
- Review
- 320 days
- Class
- Class II
- Product code
- DSA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K992524 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK992524 Patient Cables for Monitoring, I.E., Ecg, Ekg, SPO2, and BP…Advantage Medical Electronics, Inc. · 2000
- 2 generations backK082959 Patient Monitoring Cables for Ecg, Ekg, SPO2 and Blood Pressure…Unimed Medical Supplies, Inc. · 2008
- 1 generation backK120010 Cable/ Lead-Wire (Ecg, Ekg, SPO2 and Invasive Blood Pressure)Shenzhen Med-Link Electronics Tech Co., Ltd. · 2012
- This deviceK162768 ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2…Integral Process Sas · 2017
- Descendant · cites it directly · 0 of its ownK252827 IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489)…Drägerwerk AG & Co. KGaA · 2025
- Descendant · cites it directly · 0 of its ownK251669 IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer…Shanghai Draeger Medical Instrument Co., Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See all- K252827IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott…Drägerwerk AG & Co. KGaA · 2025 · cites it directly0descendants
- K251669IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger…Shanghai Draeger Medical Instrument Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K992524 | Patient Cables for Monitoring, I.E., Ecg, Ekg, SPO2, and BP Interface Cables… | Advantage Medical Electronics, Inc. | 2000 | — |
| −2 | K082959 | Patient Monitoring Cables for Ecg, Ekg, SPO2 and Blood Pressure Monitors | Unimed Medical Supplies, Inc. | 2008 | — |
| −1 | K120010 | Cable/ Lead-Wire (Ecg, Ekg, SPO2 and Invasive Blood Pressure) | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2012 | — |
| 0 (this device) | K162768 | ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and… | Integral Process Sas | 2017 | — |
| +1 | K252827 | IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable… | Drägerwerk AG & Co. KGaA | 2025 | — |
| +1 | K251669 | IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter… | Shanghai Draeger Medical Instrument Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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 DSA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DSA device
- #1 K252827 IBP cable Becton Dickinson (2606488); IBP…score 11.3 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K120010 | Cable/ Lead-Wire (Ecg, Ekg, SPO2 and Invasive Blood Pressure)Summary page 4…cate Devices: Substantial Equivalence K# Manufacturer / Current marketer Device I/D EKG/ECG, SpO2, IBP Cables K120010 Shenzhen Med-link ElectronicsTech Co., Ltd. Cable/ lead-wire (ECG, Buil… | 2012 |
| * | K992524 | Patient Cables for Monitoring, I.E., Ecg, Ekg, SPO2, and BP Interface Cables and LeadwiresSummary page 4…Blood Pressure) (*) District 518109 Shenzhen City, P.R.China EKG/ECG, SpO2, IBP Cables K992524 Advantage Medical Cables, Inc. Patient Monitoring Cables 1… | 2000 |
| * | K082959 | Patient Monitoring Cables for Ecg, Ekg, SPO2 and Blood Pressure MonitorsSummary page 4…2 and Coral Springs, FL 33076 USA Blood Pressure Monitors (*) EKG/ECG, SpO2, IBP Cables K082959 Unimed Medical Supplies, Inc. Patient monitoring Cables N… | 2008 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K252827 (Drägerwerk AG & Co. KGaA, 2025) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K120010.
How does its category compare?
All DSA devicesDSA Cable, Transducer And Electrode, Patient, (Including Connector): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DSA
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSA
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSA
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSA
67in 2025
MAUDE reports naming product code DSA, 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 | 2 | — | 0 | 4 |
| 2008 | 6 | 59 | 0 | 11 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 4 | 55 | 2 | 1 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 1 | — | 0 | 23 |
| 2014 | 1 | — | 0 | 67 |
| 2015 | 0 | — | 0 | 34 |
| 2016 | 2 | — | 0 | 28 |
| 2017 | 5 | 140 | 0 | 5 |
| 2018 | 3 | 84 | 0 | 16 |
| 2019 | 4 | 140 | 0 | 11 |
| 2020 | 6 | 177 | 0 | 31 |
| 2021 | 4 | 164 | 0 | 7 |
| 2022 | 2 | — | 1 | 49 |
| 2023 | 3 | 240 | 0 | 29 |
| 2024 | 3 | 102 | 0 | 40 |
| 2025 | 4 | 105 | 0 | 67 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Integral-Process Medical Patient Cable and Leadwire Systems are intended to be used with various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes such as ECG, EKG, SpO2 and Blood Pressure equipment. They are solely intended to be used between the electrode in contact with the patient's skin and the recording/monitoring device. This cabling facilitates the conduction of signals between the patient and the monitoring device. Integral-Process Medical Patient Cable and Leadwire Systems are limited by the Indications for Use of the connected recording/monitoring device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162768 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162768: ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162768
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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