510(k) · Cleared
ClearedTyco Electronics Electrocardiograph (Ecg) Leadwire Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyco Electronics Corporation · DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Cleared on Sep 10, 2010 as substantially equivalent to K020531 (Philips Medical Systems, 2002) after a 15-day review. Its family tree reaches back 7 generations to 1994. 6 later devices descend from it.
- Decided
- Sep 10, 2010
- Review
- 15 days
- Class
- Class II
- Product code
- DSA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K941811 (1994). 34 ancestors in all, the oldest K872781 (1987). 6 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 6 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 5 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 4 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 3 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 2 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 1 generation backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- This deviceK102430 Tyco Electronics Electrocardiograph (Ecg) Leadwire SetTyco Electronics Corporation · 2010
- Descendant · cites it directly · 5 of its ownK110287 Philips Ecg Leadwire SetPhilips Medical Systems · 2011 · Recalled
- Descendant · 2 generations on · 4 of its ownK142489 Unimed Disposable ECG lead wiresUnimed Medical Supplies, Inc. · 2014
- Descendant · 3 generations on · 2 of its ownK203635 Patient Monitoring CablesJkh USA, LLC · 2021
- Descendant · 4 generations on · 0 of its ownK240156 LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU…Physio-Control, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK222712 Fogg System Patient Monitoring CablesFogg System Company, Inc. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K110287Philips Ecg Leadwire SetPhilips Medical Systems · 2011 · cites it directly5descendants
- K142489Unimed Disposable ECG lead wiresUnimed Medical Supplies, Inc. · 2014 · 2 generations on4descendants
- K203635Patient Monitoring CablesJkh USA, LLC · 2021 · 3 generations on2descendants
- K240156LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV…Physio-Control, Inc. · 2024 · 4 generations on0descendants
- K222712Fogg System Patient Monitoring CablesFogg System Company, Inc. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −6 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −5 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −4 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −3 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −2 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −1 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| 0 (this device) | K102430 | Tyco Electronics Electrocardiograph (Ecg) Leadwire Set | Tyco Electronics Corporation | 2010 | — |
| +1 | K110287 | Philips Ecg Leadwire Set | Philips Medical Systems | 2011 | 1 |
| +2 | K142489 | Unimed Disposable ECG lead wires | Unimed Medical Supplies, Inc. | 2014 | — |
| +3 | K203635 | Patient Monitoring Cables | Jkh USA, LLC | 2021 | — |
| +4 | K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical… | Physio-Control, Inc. | 2024 | — |
| +4 | 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 | 7 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release…Summary page 1…Name: EGG Cables Product Code: DSA 510(k) Owner: Philips Medical Systems (Andover, MA) 510(k) Number: #K020531 (cleared March 20, 2002) 4.4 Device Description Tyco Electronics Electrocardiograph (ECG) Leadwire Sets are intended… | 2002 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110287 | Philips Ecg Leadwire Set | 2011 | 5 |
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 16 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 34 ancestors has a recall of any class.
- Of its descendants, K110287 (Philips Medical Systems, 2011) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K020531.
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. 2010, 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?
Tyco Electronics Electrocardiograph (ECG) Leadwire Sets 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/K102430 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102430: Tyco Electronics Electrocardiograph (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/K102430
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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