510(k) · Cleared
ClearedSmartflow, Model Sfip 2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Florence Medical, Ltd. · DSK Computer, Blood-Pressure
Cleared on May 14, 2001 after a 221-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 49 later devices descend from it.
- Decided
- May 14, 2001
- Review
- 221 days
- Class
- Class II
- Product code
- DSK
- Recalls
- None
- Predicates
- 0
49 later devices descend from it, 2 citing it directly.
- This deviceK003122 Smartflow, Model Sfip 2000Florence Medical, Ltd. · 2001
- Descendant · cites it directly · 48 of its ownK012947 SmartflowFlorence Medical, Ltd. · 2001
- Descendant · cites it directly · 47 of its ownK020127 Smartflow Pulse Transmission CoefficientFlorence Medical, Ltd. · 2002
- Descendant · 2 generations on · 46 of its ownK022188 Radianalyzer, Model 12710Radi Medical Systems AB · 2002
- Descendant · 3 generations on · 26 of its ownK042628 Modification to: Radianalyzer, Model 12711Radi Medical Systems AB · 2005
- Descendant · 3 generations on · 26 of its ownK031662 Pressure Wire Sensor, Models 12004/12304Radi Medical Systems AB · 2003
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K012947SmartflowFlorence Medical, Ltd. · 2001 · cites it directly48descendants
- K020127Smartflow Pulse Transmission CoefficientFlorence Medical, Ltd. · 2002 · cites it directly47descendants
- K022188Radianalyzer, Model 12710Radi Medical Systems AB · 2002 · 2 generations on46descendants
- K042628Modification to: Radianalyzer, Model 12711Radi Medical Systems AB · 2005 · 3 generations on26descendants
- K031662Pressure Wire Sensor, Models 12004/12304Radi Medical Systems AB · 2003 · 3 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003122 | Smartflow, Model Sfip 2000 | Florence Medical, Ltd. | 2001 | — |
| +1 | K012947 | Smartflow | Florence Medical, Ltd. | 2001 | — |
| +1 | K020127 | Smartflow Pulse Transmission Coefficient | Florence Medical, Ltd. | 2002 | — |
| +2 | K022188 | Radianalyzer, Model 12710 | Radi Medical Systems AB | 2002 | — |
| +3 | K042628 | Modification to: Radianalyzer, Model 12711 | Radi Medical Systems AB | 2005 | — |
| +3 | K031662 | Pressure Wire Sensor, Models 12004/12304 | Radi Medical Systems AB | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 7 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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 DSK? 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 DSK device
- #1 K231586 Endophys Blood Pressure Monitor model BPM-30score 8.7 · 9 generations · no Class I recall
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? (49)
See all 492 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K012947 (Florence Medical, Ltd., 2001) has gone furthest, with 48 descendants of its own.
How does its category compare?
All DSK devicesDSK Computer, Blood-Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSK
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DSK
Too few DSK 510(k)s in any year since 2007 to give a median.
Recalls per year · DSK
No recall names DSK since 2007.
Adverse event reports per year · DSK
26in 2025
MAUDE reports naming product code DSK, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 69 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 1 | — | 0 | 13 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 93 |
| 2019 | 0 | — | 0 | 148 |
| 2020 | 0 | — | 0 | 29 |
| 2021 | 0 | — | 0 | 31 |
| 2022 | 0 | — | 0 | 29 |
| 2023 | 1 | — | 0 | 14 |
| 2024 | 0 | — | 0 | 12 |
| 2025 | 0 | — | 0 | 26 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K003122 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003122: Smartflow, Model Sfip 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003122
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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