510(k) · Cleared
ClearedPatient Monitoring Cables
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jkh USA, LLC · DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Cleared on Feb 5, 2021 as substantially equivalent to K082959 (Unimed Medical Supplies, Inc., 2008) and 1 other predicate after a 53-day review. Its family tree reaches back 10 generations to 1994. 2 later devices descend from it.
- Decided
- Feb 5, 2021
- Review
- 53 days
- Class
- Class II
- Product code
- DSA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K941811 (1994). 39 ancestors in all, the oldest K872781 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 6 generations between
- 3 generations backK102430 Tyco Electronics Electrocardiograph (Ecg) Leadwire SetTyco Electronics Corporation · 2010
- 2 generations backK110287 Philips Ecg Leadwire SetPhilips Medical Systems · 2011 · Recalled
- 1 generation backK142489 Unimed Disposable ECG lead wiresUnimed Medical Supplies, Inc. · 2014
- This deviceK203635 Patient Monitoring CablesJkh USA, LLC · 2021
- Descendant · cites it directly · 0 of its ownK240156 LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU…Physio-Control, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK222712 Fogg System Patient Monitoring CablesFogg System Company, Inc. · 2023
Show all 10 generations
- Root · 10 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 9 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 8 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 7 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 6 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 5 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 4 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 3 generations backK102430 Tyco Electronics Electrocardiograph (Ecg) Leadwire SetTyco Electronics Corporation · 2010
- 2 generations backK110287 Philips Ecg Leadwire SetPhilips Medical Systems · 2011 · Recalled
- 1 generation backK142489 Unimed Disposable ECG lead wiresUnimed Medical Supplies, Inc. · 2014
- This deviceK203635 Patient Monitoring CablesJkh USA, LLC · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −9 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −8 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −7 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −6 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −5 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −4 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −3 | K102430 | Tyco Electronics Electrocardiograph (Ecg) Leadwire Set | Tyco Electronics Corporation | 2010 | — |
| −2 | K110287 | Philips Ecg Leadwire Set | Philips Medical Systems | 2011 | 1 |
| −1 | K142489 | Unimed Disposable ECG lead wires | Unimed Medical Supplies, Inc. | 2014 | — |
| 0 (this device) | K203635 | Patient Monitoring Cables | Jkh USA, LLC | 2021 | — |
| +1 | K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical… | Physio-Control, Inc. | 2024 | — |
| +1 | K222712 | Fogg System Patient Monitoring Cables | Fogg System Company, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 8 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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 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? (2)
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 |
|---|---|---|---|
| * | K082959 | Patient Monitoring Cables for Ecg, Ekg, SPO2 and Blood Pressure MonitorsSummary page 4…Electrode, Patient, (Including Connector) Regulation Number: 21 CFR 870.2900 Product Code: DSA Predicate Device 1: 510(k) Number: K082959 Device Name: Patient monitoring Cables for ECG, EKG, SpO2 and Blood Pressure Monitors… | 2008 |
| * | K142489 | Unimed Disposable ECG lead wiresSummary page 4…EKG, SpO2 and Blood Pressure Monitors Manufacturer: UNIMED MEDICAL SUPPLIES INC Predicate Device 2: 510(k) Number: K142489 Device Name: Unimed Disposable ECG Lead Wires Manufacturer: UNIMED MEDICAL SUPPLIES INC Descriptio… | 2014 |
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 27 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 39 ancestors have a recall of any class.
- Of its descendants, K240156 (Physio-Control, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K082959.
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. 2021, 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?
The Patient Monitoring Cables are intended to be used with ECG, EKG, Spo2 and BP monitoring devices. The Patient Monitoring Cables are used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by heath care professional.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203635 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203635: Patient Monitoring Cables.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203635
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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