510(k) · Cleared
ClearedHemoSphere Stream Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences · DQK Computer, Diagnostic, Programmable
Cleared on Oct 21, 2025 as substantially equivalent to K243781 (Edwards Lifesciences, 2025) after a 29-day review. Its family tree reaches back 41 generations to 1994. 3 of the 401 devices in its family, counting itself, have a Class I recall.
- Decided
- Oct 21, 2025
- Review
- 29 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 41 generations to K941811 (1994). 400 ancestors in all, the oldest K810124 (1981). No later device cites it as a predicate yet. 3 of the 401 devices in this family, counting this one, have a Class I recall.
- Root · 41 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 37 generations between
- 3 generations backK232294 HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™…Edwards Lifesciences, LLC · 2023
- 2 generations backK242451 HemoSphere Alta Advanced Monitoring Platform…Edwards Lifesciences · 2024
- 1 generation backK243781 HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module…Edwards Lifesciences · 2025 · Recalled
- This deviceK253034 HemoSphere Stream ModuleEdwards Lifesciences · 2025
Show all 41 generations
- Root · 41 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 40 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 39 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 38 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 37 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 36 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 35 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 34 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 33 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 32 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 31 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 30 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 29 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
- 28 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
- 27 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
- 26 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
- 25 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
- 24 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
- 23 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
- 22 generations backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
- 21 generations backK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
- 20 generations backK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
- 19 generations backK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
- 18 generations backK061610 Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
- 17 generations backK063315 Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2006
- 16 generations backK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
- 15 generations backK083517 Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · Recalled
- 14 generations backK091927 Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009
- 13 generations backK100939 Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
- 12 generations backK101449 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
- 11 generations backK110622 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · Recalled
- 10 generations backK113657 Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH · 2012
- 9 generations backK122439 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2012 · Recalled
- 8 generations backK130849 Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2013 · Recalled
- 7 generations backK141015 Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2014 · Recalled
- 6 generations backK150975 Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue…Philips Medizin Systeme Boeblingen GmbH · 2015 · Recalled
- 5 generations backK161531 IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and…Philips Medizin Systeme Boeblingen GmbH · 2016 · Recalled
- 4 generations backK221704 HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP)…Edwards Lifesciences, LLC · 2022
- 3 generations backK232294 HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™…Edwards Lifesciences, LLC · 2023
- 2 generations backK242451 HemoSphere Alta Advanced Monitoring Platform…Edwards Lifesciences · 2024
- 1 generation backK243781 HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module…Edwards Lifesciences · 2025 · Recalled
- This deviceK253034 HemoSphere Stream ModuleEdwards Lifesciences · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −41 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −40 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −39 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −38 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −37 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −36 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −35 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −34 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −33 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −32 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −31 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −30 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −29 | K040304 | Philips Intellivue Patient Monitor, Models MP40 & MP50 | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −28 | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −27 | K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient… | Philips Medizin Systeme Boblingen GmbH | 2004 | — |
| −26 | K050141 | The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −25 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −24 | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −23 | K052801 | Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −22 | K053522 | Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −21 | K060221 | The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −20 | K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient… | Philips Medizin Systeme Boblingen GmbH | 2006 | 2 |
| −19 | K061052 | The Philips Intellivue Patient Monitors, Models… | Philips Medical Systems North America, Inc. | 2006 | — |
| −18 | K061610 | Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −17 | K063315 | Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| −16 | K071426 | MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007 | — |
| −15 | K083517 | Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009 | 2 |
| −14 | K091927 | Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009 | — |
| −13 | K100939 | Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010 | — |
| −12 | K101449 | Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010 | — |
| −11 | K110622 | Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011 | 2 |
| −10 | K113657 | Intellivue Patient Monitor | Philips Medizin Systeme Boblingen GmbH | 2012 | — |
| −9 | K122439 | Intellivue Patient Monitor | Philips Medizin Systeme Boeblingen GmbH | 2012 | 4 |
| −8 | K130849 | Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2013 | 8 |
| −7 | K141015 | Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2014 | 1 |
| −6 | K150975 | Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2… | Philips Medizin Systeme Boeblingen GmbH | 2015 | 1 |
| −5 | K161531 | IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement… | Philips Medizin Systeme Boeblingen GmbH | 2016 | 1 |
| −4 | K221704 | HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global… | Edwards Lifesciences, LLC | 2022 | — |
| −3 | K232294 | HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced… | Edwards Lifesciences, LLC | 2023 | — |
| −2 | K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1)… | Edwards Lifesciences | 2024 | — |
| −1 | K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10)… | Edwards Lifesciences | 2025 | 1 |
| 0 (this device) | K253034 | HemoSphere Stream Module | Edwards Lifesciences | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 2 | 0 |
| 1982 | 2 | 0 |
| 1985 | 3 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 4 | 0 |
| 1990 | 8 | 0 |
| 1991 | 11 | 0 |
| 1992 | 8 | 0 |
| 1993 | 11 | 0 |
| 1994 | 5 | 0 |
| 1995 | 11 | 0 |
| 1996 | 12 | 0 |
| 1997 | 9 | 1 |
| 1998 | 20 | 0 |
| 1999 | 12 | 0 |
| 2000 | 27 | 0 |
| 2001 | 15 | 0 |
| 2002 | 25 | 0 |
| 2003 | 17 | 0 |
| 2004 | 27 | 0 |
| 2005 | 12 | 0 |
| 2006 | 17 | 0 |
| 2007 | 8 | 0 |
| 2008 | 13 | 0 |
| 2009 | 14 | 0 |
| 2010 | 12 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 2 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 8 | 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.
3 devices in this family have 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.7 · 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? (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 | Decided |
|---|---|---|---|
| * | K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Summary page 5…lass II Class: III. Predicate Device Primary HemoSphere ClearSight Module manufactured by Edwards Lifesciences, Predicate Device: K243781 cleared July 23rd, 2025. K253034 Page 1 of 3 ==… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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.
- K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC · 2016 · 4 generations back · ◆ in the 2016 ancestors bar of FIG. 11 Class I recall
- K160084Swan Ganz CathetersEdwards Lifesciences, LLC · 2016 · 4 generations back · ◆ in the 2016 ancestors bar of FIG. 14 Class I recalls
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · 13 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 31 years and passes through 10 companies; a new generation was cleared every 5 months on median.
- 82 of the 400 ancestors have a recall of any class; 3 have a Class I recall.
- 1 other device also cites its predicate K243781.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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 HemoSphere Stream™ Module when used with a Smart Pressure Controller (PC1Q) and VitaWave™ Plus Finger Cuff is indicated for use in adult patients to provide continuous, non-invasive arterial pressure waveform output to a compatible multi-parameter patient monitor. The device is designed for use in clinical environments requiring continuous assessment of blood pressure waveform morphology, without the need for an invasive catheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253034 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253034: HemoSphere Stream Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253034
Report an extraction error
Are you the manufacturer?
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