510(k) · Cleared

Cleared

T-Wave Altermans (Twa) Algorithm Option

K023380510(k) TraditionalCleared Dec 3, 200256-day reviewClass II21 CFR 870.1425

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

General Electric Medical Systems Information Techn · DQK Computer, Diagnostic, Programmable

Cleared on Dec 3, 2002 as substantially equivalent to K991014 (General Electric Medical Systems Information Techn, 1999) after a 56-day review. Its family tree reaches back 3 generations to 1991. 31 later devices descend from it.

Decided: Dec 3, 2002
Review: 56 days
Class: Class II
Product code: DQK
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K903644 (1991). 5 ancestors in all. 31 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 3 generations backK903644 Series 1500 12-Lead Analysis OptionMarquette Electronics, Inc. · 1991
2 generations backK973403 Cardiosmart STMarquette Medical Systems, Inc. · 1998
1 generation backK991014 Case 8000 Exercise Testing SystemGeneral Electric Medical Systems Information Techn · 1999
This deviceK023380 T-Wave Altermans (Twa) Algorithm OptionGeneral Electric Medical Systems Information Techn · 2002
Descendant · cites it directly · 30 of its ownK031561 Cardiosoft/Case Cardiac Testing SystemGe Medical Systems Information Technologies · 2003
Descendant · 2 generations on · 18 of its ownK092010 PC Ecg, Model SE-1010Edan Instruments, Inc. · 2009
Descendant · 2 generations on · 13 of its ownK102854 PC ECGEdan Instruments, Inc. · 2010
Descendant · 3 generations on · 12 of its ownK131819 PC ECGEdan Instruments, Inc. · 2013
Descendant · 4 generations on · 11 of its ownK152427 PC ECGEdan Instruments, Inc. · 2016

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2003high 4 (2014) · low 0 (2004)2026

Most influential descendants

Showing 5 of 31 · See all

K031561Cardiosoft/Case Cardiac Testing SystemGe Medical Systems Information Technologies · 2003 · cites it directly30descendants
K092010PC Ecg, Model SE-1010Edan Instruments, Inc. · 2009 · 2 generations on18descendants
K102854PC ECGEdan Instruments, Inc. · 2010 · 2 generations on13descendants
K131819PC ECGEdan Instruments, Inc. · 2013 · 3 generations on12descendants
K152427PC ECGEdan Instruments, Inc. · 2016 · 4 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K903644	Series 1500 12-Lead Analysis Option	Marquette Electronics, Inc.	1991	—
−2	K973403	Cardiosmart ST	Marquette Medical Systems, Inc.	1998	—
−1	K991014	Case 8000 Exercise Testing System	General Electric Medical Systems Information Techn	1999	—
0 (this device)	K023380	T-Wave Altermans (Twa) Algorithm Option	General Electric Medical Systems Information Techn	2002	—
+1	K031561	Cardiosoft/Case Cardiac Testing System	Ge Medical Systems Information Technologies	2003	—
+2	K092010	PC Ecg, Model SE-1010	Edan Instruments, Inc.	2009	—
+2	K102854	PC ECG	Edan Instruments, Inc.	2010	—
+3	K131819	PC ECG	Edan Instruments, Inc.	2013	—
+4	K152427	PC ECG	Edan Instruments, Inc.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2008	1	0
2009	3	0
2010	3	0
2011	1	0
2013	2	0
2014	4	0
2015	2	0
2016	2	0
2017	2	0
2018	1	0
2020	1	0
2021	1	0
2022	2	0
2023	3	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K023380, 1991–2026Source: 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 DQK? 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 DQK device

#1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 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
*	K991014	Case 8000 Exercise Testing System Summary page 1 …21 CFR 870.1425 Programmable diagnostic computer Classification Number: 74 DQK Predicate Devices: K991014 CASE 8000 Exercise Testing System Device DescriDtion: T-Wave Altemans (lWA) Algorithm Option is a software algorithm th…	General Electric Medical Systems Information Techn	1999	—

Also cleared against K991014: 2 other devices →

What descends from it? (31)

See all 31

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

Number	Device	Applicant	Decided	Descendants
K031561	Cardiosoft/Case Cardiac Testing System	Ge Medical Systems Information Technologies	2003	30

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 11 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
None of the 5 ancestors has a recall.
Of its descendants, K031561 (Ge Medical Systems Information Technologies, 2003) has gone furthest, with 30 descendants of its own.
2 other devices also cite its predicate K991014.

How does its category compare?

All DQK devices

DQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQK

23so far in 2026, the most since 2007

2007high 23 (2026) · low 4 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQK

95in 2025

2007high 190 (2016) · low 64 (2010)2026

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

Recalls per year · DQK

1in 2025

2007high 24 (2024) · low 0 (2016)2026

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

Adverse event reports per year · DQK

433in 2025

2007high 557 (2024) · low 18 (2007)2025

MAUDE reports naming product code DQK, 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	13	83	4	18
2008	4	70	1	34
2009	12	93	2	40
2010	9	64	3	49
2011	12	69	2	55
2012	7	74	3	129
2013	13	68	1	180
2014	9	90	4	115
2015	7	125	2	131
2016	15	190	0	340
2017	7	146	2	252
2018	14	150	6	261
2019	15	113	1	218
2020	16	123	1	215
2021	16	132	1	351
2022	19	136	2	319
2023	21	133	2	340
2024	13	100	24	557
2025	22	95	1	433
2026	23	151	2	—

What is it indicated for?

The T-Wave Attemans (TWA) Algorithm Option is to be used in a hospital, doctor's office, or clinic environment by competent health care professionals for recording ST-T wave morphology fluctuations for patients who are undergoing Cardiovascular disease testing.

The T-Wave alternans analysis is intended to provide only the measurements of the fluctuations of the ST-T-waves. The T-Wave alternans measurements produced by the T-Wave Alternans analysis are intended to be used by qualified personnel in evaluating the patient in conjunction with the patients clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgment. No interpretation is generated.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023380 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023380: T-Wave Altermans (Twa) Algorithm Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023380

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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