510(k) · Cleared

Recalled · 2002

Cathcor Desktop

K002137510(k) TraditionalCleared Oct 5, 200083-day reviewClass II21 CFR 870.1425Recalls 1

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

Siemens Elema AB · DQK Computer, Diagnostic, Programmable

Cleared on Oct 5, 2000 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it. It has been recalled once.

Decided: Oct 5, 2000
Review: 83 days
Class: Class II
Product code: DQK
Recalls: 1
Predicates: 0

10 later devices descend from it, 2 citing it directly.

This deviceK002137 Cathcor DesktopSiemens Elema AB · 2000
Descendant · cites it directly · 9 of its ownK020440 NewcorSiemens Medical Systems, Inc. · 2002 · Recalled
Descendant · 2 generations on · 5 of its ownK101571 Xper Information Management and Flex Cardio Physiomonitoring SystemsWitt Biomedical Corp · 2010 · Recalled
Descendant · 3 generations on · 3 of its ownK131497 Mckesson Cardiology HemoMckesson Israel, Ltd. · 2013 · Recalled
Descendant · 2 generations on · 2 of its ownK131812 Sensis, Sensis LiteSiemens Medi Cal Solutions, Inc. · 2013
Descendant · 4 generations on · 1 of its ownK170032 QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM…Fysicon BV · 2017

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2002high 2 (2013) · low 0 (2003)2026

Most influential descendants

Showing 5 of 10 · See all

K020440NewcorSiemens Medical Systems, Inc. · 2002 · cites it directly9descendants
K101571Xper Information Management and Flex Cardio Physiomonitoring SystemsWitt Biomedical Corp · 2010 · 2 generations on5descendants
K131497Mckesson Cardiology HemoMckesson Israel, Ltd. · 2013 · 3 generations on3descendants
K131812Sensis, Sensis LiteSiemens Medi Cal Solutions, Inc. · 2013 · 2 generations on2descendants
K170032QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EPFysicon BV · 2017 · 4 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K002137	Cathcor Desktop	Siemens Elema AB	2000	—
+1	K020440	Newcor	Siemens Medical Systems, Inc.	2002	10
+2	K101571	Xper Information Management and Flex Cardio Physiomonitoring Systems	Witt Biomedical Corp	2010	8
+3	K131497	Mckesson Cardiology Hemo	Mckesson Israel, Ltd.	2013	10
+2	K131812	Sensis, Sensis Lite	Siemens Medi Cal Solutions, Inc.	2013	—
+4	K170032	QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO…	Fysicon BV	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2010	1	0
2013	2	0
2015	1	0
2017	1	0
2018	1	0
2023	2	0
2025	1	0

FIG. 1 — Lineage of K002137, 2000–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (10)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K020440	Newcor	Siemens Medical Systems, Inc.	2002	9
K150493	Sensis	Siemens Medi Cal Solutions, Inc.	2015	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 27, 2002	Not classified	Z-1032-03	Other	Incorrect CTR values are found when used with ODBC interface, and may result in misdiagnosis.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K020440 (Siemens Medical Systems, Inc., 2002) has gone furthest, with 9 descendants of its own.

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	—

https://510kreport.com/device/K002137 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002137: Cathcor Desktop.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002137

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026