510(k) · Cleared
ClearedModification to Bioz.Com Hemodynamic Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiodynamics International Corp. · DSB Plethysmograph, Impedance
Cleared on Nov 2, 2001 after a 176-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Nov 2, 2001
- Review
- 176 days
- Class
- Class II
- Product code
- DSB
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 3 citing it directly.
- This deviceK011439 Modification to Bioz.Com Hemodynamic MonitorCardiodynamics International Corp. · 2001
- Descendant · cites it directly · 4 of its ownK070985 Aesculon CHF, Hypertension & Pacemaker ClinicOsypka Medical, Inc. · 2008
- Descendant · cites it directly · 4 of its ownK070156 Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100Cardiodynamics International Corp. · 2007
- Descendant · 2 generations on · 3 of its ownK081035 Aesculon C2, Aesculon CHF Clinic C2, Aesculon Hypertension Clinic C2…Osypka Medical, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK150095 ReDs Wearable SystemSensible Medical Innovations, Ltd. · 2015
- Descendant · 2 generations on · 1 of its ownK090602 Cardiodynamics Bioz RX, Model 7101-SysCardiodynamics International Corp. · 2009
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K070985Aesculon CHF, Hypertension & Pacemaker ClinicOsypka Medical, Inc. · 2008 · cites it directly4descendants
- K070156Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100Cardiodynamics International Corp. · 2007 · cites it directly4descendants
- K081035Aesculon C2, Aesculon CHF Clinic C2, Aesculon Hypertension Clinic C2 and Aesculon…Osypka Medical, Inc. · 2008 · 2 generations on3descendants
- K150095ReDs Wearable SystemSensible Medical Innovations, Ltd. · 2015 · 2 generations on1descendant
- K090602Cardiodynamics Bioz RX, Model 7101-SysCardiodynamics International Corp. · 2009 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011439 | Modification to Bioz.Com Hemodynamic Monitor | Cardiodynamics International Corp. | 2001 | — |
| +1 | K070985 | Aesculon CHF, Hypertension & Pacemaker Clinic | Osypka Medical, Inc. | 2008 | — |
| +1 | K070156 | Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100 | Cardiodynamics International Corp. | 2007 | — |
| +2 | K081035 | Aesculon C2, Aesculon CHF Clinic C2, Aesculon Hypertension Clinic C2 and… | Osypka Medical, Inc. | 2008 | — |
| +2 | K150095 | ReDs Wearable System | Sensible Medical Innovations, Ltd. | 2015 | — |
| +2 | K090602 | Cardiodynamics Bioz RX, Model 7101-Sys | Cardiodynamics International Corp. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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 DSB? 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 DSB device
- #1 K232089 SOZO Proscore 14.6 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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? (11)
See all 113 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, K070985 (Osypka Medical, Inc., 2008) has gone furthest, with 4 descendants of its own.
How does its category compare?
All DSB devicesDSB Plethysmograph, Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSB
266in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSB
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSB
2in 2025
MAUDE reports naming product code DSB, 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 | 2 | — | 0 | 0 |
| 2008 | 6 | 90 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 2 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 3 | 266 | 0 | 2 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K011439 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011439: Modification to Bioz.Com Hemodynamic Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011439
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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