510(k) · Cleared
Recalled · Class II · 2019Philips Ecg Leadwire Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Cleared on Feb 15, 2011 as substantially equivalent to K102430 (Tyco Electronics Corporation, 2010) after a 15-day review. Its family tree reaches back 8 generations to 1994. 5 later devices descend from it. It has been recalled once.
- Decided
- Feb 15, 2011
- Review
- 15 days
- Class
- Class II
- Product code
- DSA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 8 generations to K941811 (1994). 35 ancestors in all, the oldest K872781 (1987). 5 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 7 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 6 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 5 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 4 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 3 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 2 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 1 generation backK102430 Tyco Electronics Electrocardiograph (Ecg) Leadwire SetTyco Electronics Corporation · 2010
- This deviceK110287 Philips Ecg Leadwire SetPhilips Medical Systems · 2011
- Descendant · cites it directly · 4 of its ownK142489 Unimed Disposable ECG lead wiresUnimed Medical Supplies, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK203635 Patient Monitoring CablesJkh USA, LLC · 2021
- Descendant · 3 generations on · 0 of its ownK240156 LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU…Physio-Control, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK222712 Fogg System Patient Monitoring CablesFogg System Company, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK153188 Caremed patient cable and leadwiresShenzhen Caremed Medical Technology Co., Ltd. · 2016
Most influential descendants
Showing 5 of 5 · See all- K142489Unimed Disposable ECG lead wiresUnimed Medical Supplies, Inc. · 2014 · cites it directly4descendants
- K203635Patient Monitoring CablesJkh USA, LLC · 2021 · 2 generations on2descendants
- K240156LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV…Physio-Control, Inc. · 2024 · 3 generations on0descendants
- K222712Fogg System Patient Monitoring CablesFogg System Company, Inc. · 2023 · 3 generations on0descendants
- K153188Caremed patient cable and leadwiresShenzhen Caremed Medical Technology Co., Ltd. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −7 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −6 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −5 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −4 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −3 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −2 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −1 | K102430 | Tyco Electronics Electrocardiograph (Ecg) Leadwire Set | Tyco Electronics Corporation | 2010 | — |
| 0 (this device) | K110287 | Philips Ecg Leadwire Set | Philips Medical Systems | 2011 | — |
| +1 | K142489 | Unimed Disposable ECG lead wires | Unimed Medical Supplies, Inc. | 2014 | — |
| +2 | K203635 | Patient Monitoring Cables | Jkh USA, LLC | 2021 | — |
| +3 | K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical… | Physio-Control, Inc. | 2024 | — |
| +3 | K222712 | Fogg System Patient Monitoring Cables | Fogg System Company, Inc. | 2023 | — |
| +2 | K153188 | Caremed patient cable and leadwires | Shenzhen Caremed Medical Technology Co., Ltd. | 2016 | — |
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 | 7 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K102430 | Tyco Electronics Electrocardiograph (Ecg) Leadwire SetSummary page 2…EGG Leadwire Set 510(k) Pagel 17f4 Predicate Device Details 510(k) Number K1 02430 (cleared on September 10, 2010) Proprietary or Trade Name: Tyco Electronics Electrocardiograph (ECG)… | 2010 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142489 | Unimed Disposable ECG lead wires | 2014 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 19, 2019 | Class II | Z-2495-2019 | Nonconforming Material/Component | The thickness of the connector to the trunk cable on affected limb lead sets may be greater than specified. which may prevent or impede the performance of I 2-Lead ECG measurements. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 35 ancestors has a recall of any class.
- Of its descendants, K142489 (Unimed Medical Supplies, Inc., 2014) has gone furthest, with 4 descendants of its own.
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. 2011, 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?
Philips ECG leadsets are indicated for use in the monitoring of cardiac signals for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110287 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110287: Philips Ecg Leadwire Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110287
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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