510(k) · Cleared
ClearedDiagnostic Station DS20
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schiller AG · DPS Electrocardiograph
Cleared on May 6, 2016 as substantially equivalent to K050686 (Schiller AG, 2005) and 5 other predicates after a 288-day review. Its family tree reaches back 14 generations to 1997. 1 of the 118 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- May 6, 2016
- Review
- 288 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 14 generations to K962603 (1997). 116 ancestors in all, the oldest K842616 (1984). 1 later device descends from it, 1 citing it directly. 1 of the 118 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 10 generations between
- 3 generations backK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- 2 generations backK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
- 1 generation backK110028 Masimo Radical Y Pulse CO-OximeterMasimo Corporation · 2011
- This deviceK152043 Diagnostic Station DS20Schiller AG · 2016
- Descendant · cites it directly · 0 of its ownK170182 Cardiovit FT-1Schiller AG · 2017
Show all 14 generations
- Root · 14 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 13 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 12 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 11 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 10 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 9 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 8 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 7 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 6 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 5 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 4 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 3 generations backK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- 2 generations backK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
- 1 generation backK110028 Masimo Radical Y Pulse CO-OximeterMasimo Corporation · 2011
- This deviceK152043 Diagnostic Station DS20Schiller AG · 2016
Class I recalls in this family
- K970209 Capnocheck Plus6 generations back · 1997
Most influential descendants
Showing 1 of 1 · See all- K170182Cardiovit FT-1Schiller AG · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −13 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −12 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −11 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −10 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −9 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −8 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −7 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −6 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| −5 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| −4 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| −3 | K091241 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter | Masimo Corporation | 2009 | — |
| −2 | K100428 | Masimo Rainbow Set Radical 7R Pulse CO-Oximeter | Masimo Corporation | 2010 | — |
| −1 | K110028 | Masimo Radical Y Pulse CO-Oximeter | Masimo Corporation | 2011 | — |
| 0 (this device) | K152043 | Diagnostic Station DS20 | Schiller AG | 2016 | — |
| +1 | K170182 | Cardiovit FT-1 | Schiller AG | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 6 | 0 |
| 1992 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 8 | 0 |
| 1996 | 5 | 0 |
| 1997 | 8 | 1 |
| 1998 | 9 | 0 |
| 1999 | 5 | 0 |
| 2000 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 7 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 5 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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.
1 device in this family has a Class I recall. 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 DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 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 |
|---|---|---|---|
| * | K050686 | Cardiovit at-10PLUSSummary page 5…Predicate Scope Predicate Device 510(k) Classification Primary Predicate SCHILLER Cardiovit AT-10 Plus K050686 DPS (12-lead ECG Electrocardiograph with Spirometry option) OEM Module SCHILLER BP-200 Plus… | 2005 |
| * | K063814 | BP-200 PlusSummary page 5…iovit AT-10 Plus K050686 DPS (12-lead ECG Electrocardiograph with Spirometry option) OEM Module SCHILLER BP-200 Plus K063814 DXN Non-invasive Blood Pressure (NIBP) OEM Module Covidien Respiratory Patient K130320… | 2007 |
| * | K130320 | Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring…Summary page 5…SCHILLER BP-200 Plus K063814 DXN Non-invasive Blood Pressure (NIBP) OEM Module Covidien Respiratory Patient K130320 DQA Pulse Oximetry (SpO2) Monitor OEM Module Masimo Radical 7… | 2014 |
| * | K110028 | Masimo Radical Y Pulse CO-OximeterSummary page 5…vidien Respiratory Patient K130320 DQA Pulse Oximetry (SpO2) Monitor OEM Module Masimo Radical 7 K110028 DQA, JKS Pulse Oximetry (SpO2, SpCO) OEM Module Zoe Medical Nightingale K130740… | 2011 |
| * | K130740 | Nightingale Monitoring SystemSummary page 5…Masimo Radical 7 K110028 DQA, JKS Pulse Oximetry (SpO2, SpCO) OEM Module Zoe Medical Nightingale K130740 MWI 5-lead ECG and Respiration Monitoring System OEM Module Exergen… | 2013 |
| * | K011291 | Temporalscanner Thermometer, SensortouchSummary page 5…Nightingale K130740 MWI 5-lead ECG and Respiration Monitoring System OEM Module Exergen K011291 FLL Temperature Temporal Scanner Thermometer IV. DEVICE DESCRIPTION The Diagnostic Station D… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170182 | Cardiovit FT-1 | 2017 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · 6 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 20 of the 116 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K170182 (Schiller AG, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K050686.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
The Diagnostic Station DS20 is a 12-lead EGG device used for the recording, analysis and evaluation of ECG waveforms. Recordings made with the DS20 can be used as a diagnostic aid for heart function and heart conditions. The DS20 also measures the following patient vital information to further aid in patient assessment: pulmonary lung function (spirometry), blood pressure, functional oxygen saturation of arterial hemoglobin (SpO2), carboxyhemoglobin…
Read the full statement (111 words)
The Diagnostic Station DS20 is a 12-lead EGG device used for the recording, analysis and evaluation of ECG waveforms.
Recordings made with the DS20 can be used as a diagnostic aid for heart function and heart conditions.
The DS20 also measures the following patient vital information to further aid in patient assessment: pulmonary lung function (spirometry), blood pressure, functional oxygen saturation of arterial hemoglobin (SpO2), carboxyhemoglobin saturation (SpCO), respiration, temperature, and weight.
The DS20 is intended for data collection only. It is not intended for continuous monitoring use and does not provide an alarm function.
The DS20 is indicated for use in hospital and clinic settings, on adult and pediatric patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152043: Diagnostic Station DS20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152043
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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