510(k) · Cleared
Recalled · Class II · 2017Newcor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Systems, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Dec 3, 2002 as substantially equivalent to K993414 (Prucka Engineering, Inc., 2000) and 5 other predicates after a 295-day review. Its family tree reaches back 4 generations to 1991. 9 later devices descend from it. It has been recalled 10 times.
- Decided
- Dec 3, 2002
- Review
- 295 days
- Class
- Class II
- Product code
- DQK
- Recalls
- 10
- Predicates
- 6
Its longest line of descent runs back 4 generations to K910772 (1991). 21 ancestors in all, the oldest K862740 (1986). 9 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 3 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 2 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 1 generation backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- This deviceK020440 NewcorSiemens Medical Systems, Inc. · 2002
- Descendant · cites it directly · 5 of its ownK101571 Xper Information Management and Flex Cardio Physiomonitoring SystemsWitt Biomedical Corp · 2010 · Recalled
- Descendant · 2 generations on · 3 of its ownK131497 Mckesson Cardiology HemoMckesson Israel, Ltd. · 2013 · Recalled
- Descendant · cites it directly · 2 of its ownK131812 Sensis, Sensis LiteSiemens Medi Cal Solutions, Inc. · 2013
- Descendant · 3 generations on · 1 of its ownK170032 QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM…Fysicon BV · 2017
- Descendant · 2 generations on · 1 of its ownK150493 SensisSiemens Medi Cal Solutions, Inc. · 2015 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K101571Xper Information Management and Flex Cardio Physiomonitoring SystemsWitt Biomedical Corp · 2010 · cites it directly5descendants
- K131497Mckesson Cardiology HemoMckesson Israel, Ltd. · 2013 · 2 generations on3descendants
- K131812Sensis, Sensis LiteSiemens Medi Cal Solutions, Inc. · 2013 · cites it directly2descendants
- K170032QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EPFysicon BV · 2017 · 3 generations on1descendant
- K150493SensisSiemens Medi Cal Solutions, Inc. · 2015 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −3 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −2 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −1 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| 0 (this device) | K020440 | Newcor | Siemens Medical Systems, Inc. | 2002 | — |
| +1 | K101571 | Xper Information Management and Flex Cardio Physiomonitoring Systems | Witt Biomedical Corp | 2010 | 8 |
| +2 | K131497 | Mckesson Cardiology Hemo | Mckesson Israel, Ltd. | 2013 | 10 |
| +1 | K131812 | Sensis, Sensis Lite | Siemens Medi Cal Solutions, Inc. | 2013 | — |
| +3 | K170032 | QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO… | Fysicon BV | 2017 | — |
| +2 | K150493 | Sensis | Siemens Medi Cal Solutions, Inc. | 2015 | 11 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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 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
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K993414 | Prucka Engineering Inc. Cardiolab EP System,Version 4.2Summary page 1…lence AXIOM Sensis system is substantially equivalent to the following legally market devices: GE PRUCKA CARDIOLAB@ 7000 K993414, cleared on April 7,2000 Siemens CATHCOR LX Desktop K002137, cleared on Oct 5,2000… | 2000 |
| * | K002137 | Cathcor DesktopSummary page 1…ices: GE PRUCKA CARDIOLAB@ 7000 K993414, cleared on April 7,2000 Siemens CATHCOR LX Desktop K002137, cleared on Oct 5,2000 Siemens EPCOR option K930786, cleared on Sept 26, 1994… | 2000 |
| * | K930786 | EPCORSummary page 1…l 7,2000 Siemens CATHCOR LX Desktop K002137, cleared on Oct 5,2000 Siemens EPCOR option K930786, cleared on Sept 26, 1994 Nonin NeonataVAdult Vital Sign Monitor (Sp02) K982776, cleared on Aug 9, 1998… | 1994 |
| * | K982776 | 9303 Neonatal/Adult Vital Signs MonitorSummary page 1…,2000 Siemens EPCOR option K930786, cleared on Sept 26, 1994 Nonin NeonataVAdult Vital Sign Monitor (Sp02) K982776, cleared on Aug 9, 1998 SunTech Oscar I1 BP Monitor (NIBP) K003004, cleared on Oct 25,2000… | 1998 |
| * | K003004 | Oscar 2, Model 222Summary page 1…6, 1994 Nonin NeonataVAdult Vital Sign Monitor (Sp02) K982776, cleared on Aug 9, 1998 SunTech Oscar I1 BP Monitor (NIBP) K003004, cleared on Oct 25,2000 SC9000 Infinity Monitor (HR & CO) K980882, cleared on June 5, 1998… | 2000 |
| * | K980882 | Siemens SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSummary page 1…9, 1998 SunTech Oscar I1 BP Monitor (NIBP) K003004, cleared on Oct 25,2000 SC9000 Infinity Monitor (HR & CO) K980882, cleared on June 5, 1998 Information that substantiates this claim of equivalence is provided throughout this 5 10(k)… | 1998 |
| † | K010938 | Syngo Multimodality Workstation | 2001 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 16, 2017 | Class II | Z-2688-2017 | Software design | Software error. In Sensis Vibe systems with software version VD10B, a software error can result in: problems generating a report and/ or - information from different examinations of the same patient being combined into one report. --- The… |
| Apr 12, 2017 | Class II | Z-2156-2017 | Material/Component Contamination | An extremely dusty computer can cause problems at system start, or rarely, cause system fail. Perform a system check prior to performing exams. If the Sensis system fails, its functions can not be used. Clinical treatment may need to be… |
| Feb 22, 2012 | Not classified | Z-1506-2012 | Nonconforming Material/Component | There is a potential malfunction in the connection of a Sensis EP system with Carto(R) 3 dedicated cable set (part number 14411343) with the Carto 3 system from Bionsense Webster. |
| Jul 9, 2004 | Not classified | Z-0032-05 | Other | possible error calculating valve area with the AXIOM Sensis |
| Jul 9, 2004 | Not classified | Z-0036-05 | Other | possible error calculating valve area with the AXIOM Sensis |
| Jul 9, 2004 | Not classified | Z-0033-05 | Other | possible error calculating valve area with the AXIOM Sensis |
| Jul 9, 2004 | Not classified | Z-0034-05 | Other | possible error calculating valve area with the AXIOM Sensis |
| Jul 9, 2004 | Not classified | Z-0035-05 | Other | possible error calculating valve area with the AXIOM Sensis |
| May 17, 2004 | Not classified | Z-1446-04 | Other | Software issue. Allows for users to enter date in Pre-Cath Holding Area prior to registering the patient in the Cath Lab. |
| Feb 28, 2003 | Not classified | Z-0979-03 | Other | software problem - erroneous results or system crashes |
The 5 latest of 10 recalls; the web page lists all.
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 4.1 years on median.
- 2 of the 21 ancestors have a recall of any class.
- Of its descendants, K101571 (Witt Biomedical Corp, 2010) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K993414.
How does its category compare?
All DQK devicesDQK 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
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 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 AXIOM Sensis system is intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies. The system is equipped by modules, enabling various configurations ranging from a stand-alone acquisition unit with limited administrative functionality to multiunit installations with a common database and satellite workstations accessing the data using the administrative…
Read the full statement (198 words)
The AXIOM Sensis system is intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies. The system is equipped by modules, enabling various configurations ranging from a stand-alone acquisition unit with limited administrative functionality to multiunit installations with a common database and satellite workstations accessing the data using the administrative tools.
The AXIOM Sensis system has functions for:
1. External communication via the DICOM interface by using Siemens Medical Platform syngo and AXIOM Sensis VCOOA DICOM Conformance Statement
2. External Communication via the HL7 interface by using AXIOM Sensis Interface description HL7 Interface.
3. Local communication by using the Siemens HICOR interface
4. Local communication by using the Siemens AXIOM Artis-FC/BC interface
5. Local communication with Medtronic Model 4803, Atakr II RF Power Generator, Boston Scientific EP Technologies EPT-100 TC, and Stockert EP-Shuttle Ablator devices
The device is intended to be used on either or both of the following populations:
1. Adult and pediatric populations requiring intracardiac electrophysiology examinations, typically when the patient is suffering from cardiac arrhythmias.
2. Adult and pediatric populations requiring intracardiac hemodynamic examinations, typically when the patient has a heart disease resulting in insufficient hemodynamic functionality.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020440 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020440: Newcor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020440
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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