510(k) · Cleared

Cleared

Removable Patient Leads Ecg Cable

K132253510(k) TraditionalCleared Dec 16, 2013150-day reviewClass II21 CFR 870.2900

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Boston Scientific · DSA Cable, Transducer And Electrode, Patient, (Including Connector)

Cleared on Dec 16, 2013 as substantially equivalent to K771645 (Tronomed, Inc., 1977) after a 150-day review. Its family tree reaches back 1 generation to 1977. 1 later device descends from it.

Decided: Dec 16, 2013
Review: 150 days
Class: Class II
Product code: DSA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K771645 (1977). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK771645 Electrocardiographic Cablhs & Lead WireTronomed, Inc. · 1977
This deviceK132253 Removable Patient Leads Ecg CableBoston Scientific · 2013
Descendant · cites it directly · 0 of its ownK172591 Fixed Patient Leads ECG Cable (Model 3153)Boston Scientific Corporation · 2017

Most influential descendants

Showing 1 of 1 · See all

K172591Fixed Patient Leads ECG Cable (Model 3153)Boston Scientific Corporation · 2017 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K771645	Electrocardiographic Cablhs & Lead Wire	Tronomed, Inc.	1977	—
0 (this device)	K132253	Removable Patient Leads Ecg Cable	Boston Scientific	2013	—
+1	K172591	Fixed Patient Leads ECG Cable (Model 3153)	Boston Scientific Corporation	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0

FIG. 1 — Lineage of K132253, 1977–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K771645	Electrocardiographic Cablhs & Lead Wire Summary page 1 …Taiwan ERN: 3008483389 2.2. DEVICE Removable Patient Leads ECG Cable. 2.3. PREDICATE DEVICE ECG Patient Cables & Lead Wire System, K771645 (Oct 13, 1977). Property of B~oston Scientific Corporation Confidential. Do not Copy 2-I .l llv 2013…	Tronomed, Inc.	1977	—

Also cleared against K771645: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K172591	Fixed Patient Leads ECG Cable (Model 3153)	Boston Scientific Corporation	2017	0

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?

Its one ancestor has no recall.
Of its descendants, K172591 (Boston Scientific Corporation, 2017) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K771645.

How does its category compare?

All DSA devices

DSA Cable, Transducer And Electrode, Patient, (Including Connector): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · DSA

4in 2025

2007high 6 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSA

105in 2025

2007high 240 (2023) · low 55 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DSA

1in 2022

2007high 2 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DSA

67in 2025

2007high 67 (2014) · low 1 (2010)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 BSC Removable Patient Leads ECG Cable is used to transmit signals from patient-connected electrodes or transducers to electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. ECG cables are supplied non-sterile and are not sterilizable; they are reusable devices and are recommended to be used by trained operators in a medical environment. 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/K132253 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132253: Removable Patient Leads Ecg Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132253

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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