510(k) · Cleared
ClearedSorba Steorra Non-Invasive Impedance Cardiograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorba Medical Systems, Inc. · DSB Plethysmograph, Impedance
Cleared on Jan 30, 2002 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 30, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- DSB
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
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.
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 | — |
What is it indicated for?
The Steorra™ by SORBA is a noninvasive hemodynamic monitor based on the technology of impedance cardiography. The Steorra™ measures the following cardiac parameters: heart rate (HR); stroke volume (SV) and Cardiac Output (CO) The Steorra™ can be configured with optional noninvasive blood pressure (NIBP) technology. When blood pressure data are available (via the NIBP, analog input from an invasive monitor, or manual input), then systolic, diastolic and…
Read the full statement (105 words)
The Steorra™ by SORBA is a noninvasive hemodynamic monitor based on the technology of impedance cardiography. The Steorra™ measures the following cardiac parameters: heart rate (HR); stroke volume (SV) and Cardiac Output (CO) The Steorra™ can be configured with optional noninvasive blood pressure (NIBP) technology. When blood pressure data are available (via the NIBP, analog input from an invasive monitor, or manual input), then systolic, diastolic and mean blood pressures are displayed with rate pressure product (RPP). If central venous pressure (CVP) is input as an analog signal from an invasive monitor, then CVP is displayed and systemic vascular resistance (SVR) is calculated and displayed.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K014299 · printed Nov 5, 2026
Cite this page
510(k) Report. “K014299: Sorba Steorra Non-Invasive Impedance Cardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K014299
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026