510(k) · Cleared
ClearedSmart Wedge algorithm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · DQK Computer, Diagnostic, Programmable
Cleared on Aug 18, 2023 as substantially equivalent to K213181 (GE Healthcare Finland Oy, 2022) after a 169-day review. Its family tree reaches back 9 generations to 2000. 5 later devices descend from it.
- Decided
- Aug 18, 2023
- Review
- 169 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K000815 (2000). 24 ancestors in all, the oldest K900598 (1990). 5 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK000815 AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a)Datex-Ohmeda · 2000
- 5 generations between
- 3 generations backK131223 Carescape Monitor B650GE Healthcare Finland Oy · 2013 · Recalled
- 2 generations backK191149 Carescape B650GE Healthcare Finland Oy · 2020 · Recalled
- 1 generation backK213181 CARESCAPE B650, E-musbGE Healthcare Finland Oy · 2022 · Recalled
- This deviceK230579 Smart Wedge algorithmEdwards Lifesciences, LLC · 2023
- Descendant · cites it directly · 4 of its ownK242451 HemoSphere Alta Advanced Monitoring Platform…Edwards Lifesciences · 2024
- Descendant · 2 generations on · 2 of its ownK243781 HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module…Edwards Lifesciences · 2025 · Recalled
- Descendant · 3 generations on · 0 of its ownK253186 HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK252533 HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1…Edwards Lifesciences · 2025
- Descendant · 3 generations on · 0 of its ownK253034 HemoSphere Stream ModuleEdwards Lifesciences · 2025
Show all 9 generations
- Root · 9 generations backK000815 AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a)Datex-Ohmeda · 2000
- 8 generations backK021279 Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A SoftwareDatex-Ohmeda · 2002
- 7 generations backK030812 Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A SoftwareDatex-Ohmeda · 2003
- 6 generations backK051400 Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A…GE Healthcare · 2006
- 5 generations backK092027 Carescape Monitor B850Ge Medical Systems Information Technologies · 2009 · Recalled
- 4 generations backK102239 Carescape Monitor B650GE Healthcare Finland Oy · 2010 · Recalled
- 3 generations backK131223 Carescape Monitor B650GE Healthcare Finland Oy · 2013 · Recalled
- 2 generations backK191149 Carescape B650GE Healthcare Finland Oy · 2020 · Recalled
- 1 generation backK213181 CARESCAPE B650, E-musbGE Healthcare Finland Oy · 2022 · Recalled
- This deviceK230579 Smart Wedge algorithmEdwards Lifesciences, LLC · 2023
Most influential descendants
Showing 5 of 5 · See all- K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences · 2024 · cites it directly4descendants
- K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences · 2025 · 2 generations on2descendants
- K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC · 2026 · 3 generations on0descendants
- K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences · 2025 · 2 generations on0descendants
- K253034HemoSphere Stream ModuleEdwards Lifesciences · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K000815 | AS/3 Anesthesia Montior with S-ANE99(a)/L-ARK99(a) | Datex-Ohmeda | 2000 | — |
| −8 | K021279 | Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A Software | Datex-Ohmeda | 2002 | — |
| −7 | K030812 | Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A Software | Datex-Ohmeda | 2003 | — |
| −6 | K051400 | Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO5 and L-ANEO5A Software, Using… | GE Healthcare | 2006 | — |
| −5 | K092027 | Carescape Monitor B850 | Ge Medical Systems Information Technologies | 2009 | 9 |
| −4 | K102239 | Carescape Monitor B650 | GE Healthcare Finland Oy | 2010 | 8 |
| −3 | K131223 | Carescape Monitor B650 | GE Healthcare Finland Oy | 2013 | 4 |
| −2 | K191149 | Carescape B650 | GE Healthcare Finland Oy | 2020 | 2 |
| −1 | K213181 | CARESCAPE B650, E-musb | GE Healthcare Finland Oy | 2022 | 2 |
| 0 (this device) | K230579 | Smart Wedge algorithm | Edwards Lifesciences, LLC | 2023 | — |
| +1 | K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1)… | Edwards Lifesciences | 2024 | — |
| +2 | K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10)… | Edwards Lifesciences | 2025 | 1 |
| +3 | K253186 | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | 2026 | — |
| +2 | K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences | 2025 | — |
| +3 | K253034 | HemoSphere Stream Module | Edwards Lifesciences | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K213181 | CARESCAPE B650, E-musbSummary page 4…rammable Product Code DQK Regulation Class Class II III. Predicate Device The GE CARESCAPE B650 Patient Monitor (K213181, cleared April 13, 2022) manufactured by GE Healthcare Finland Oy, and its… | 2022 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-… | 2024 | 4 |
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 23 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 11 of the 24 ancestors have a recall of any class.
- Of its descendants, K242451 (Edwards Lifesciences, 2024) has gone furthest, with 4 descendants of its own.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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?
When used in combination with a Swan-Ganz catheter connected to a pressure cable and pressure transducer, the Edwards Lifesciences Smart Wedge algorithm measures and provides pulmonary artery occlusion pressure and assesses the quality of the pulmonary artery occlusion pressure measurement. The Smart Wedge algorithm is indicated for use in critical care patients over 18 years of age receiving advanced hemodynamic monitoring. The Smart Wedge algorithm is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Smart Wedge algorithm parameters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230579 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230579: Smart Wedge algorithm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230579
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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