510(k) · Cleared
ClearedReDS System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sensible Medical Innovations, Ltd. · DSB Plethysmograph, Impedance
Cleared on Feb 28, 2019 as substantially equivalent to K150095 (Sensible Medical Innovations, Ltd., 2015) after a 371-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Feb 28, 2019
- Review
- 371 days
- Class
- Class II
- Product code
- DSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K000126 (2000). 13 ancestors in all, the oldest K922218 (1992). No later device cites it as a predicate yet.
- Root · 6 generations backK000126 Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp. · 2000
- 5 generations backK031330 Modification to Masimo Set Radical Pulse Oximeter with Satshare and…Masimo Corp. · 2003
- 4 generations backK033296 Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V…Masimo Corp. · 2004 · Recalled
- 3 generations backK070985 Aesculon CHF, Hypertension & Pacemaker ClinicOsypka Medical, Inc. · 2008
- 2 generations backK081035 Aesculon C2, Aesculon CHF Clinic C2, Aesculon Hypertension Clinic C2…Osypka Medical, Inc. · 2008
- 1 generation backK150095 ReDs Wearable SystemSensible Medical Innovations, Ltd. · 2015
- This deviceK180479 ReDS SystemSensible Medical Innovations, Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000126 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo… | Masimo Corp. | 2000 | — |
| −5 | K031330 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop… | Masimo Corp. | 2003 | — |
| −4 | K033296 | Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse… | Masimo Corp. | 2004 | 1 |
| −3 | K070985 | Aesculon CHF, Hypertension & Pacemaker Clinic | Osypka Medical, Inc. | 2008 | — |
| −2 | K081035 | Aesculon C2, Aesculon CHF Clinic C2, Aesculon Hypertension Clinic C2 and… | Osypka Medical, Inc. | 2008 | — |
| −1 | K150095 | ReDs Wearable System | Sensible Medical Innovations, Ltd. | 2015 | — |
| 0 (this device) | K180479 | ReDS System | Sensible Medical Innovations, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 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? (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 |
|---|---|---|---|
| * | K150095 | ReDs Wearable SystemSummary page 4…aphs as Class II devices (product code DSB, 21 CFR 870.2770), and they are reviewed by the Cardiovascular panel. Predicate Devices: ReDS Wearable System V2.6 (K150095) Page 1 of 8… | 2015 |
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.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 13 ancestors has a recall of any class.
How does its category compare?
All DSB devicesDSB Plethysmograph, Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
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 ReDS System is intended for use by qualified healthcare practitioners, under the direction of a physician, in hospitals, hospital-type facilities and home environments, for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.
The ReDS System is indicated for patients:
* With fluid management problems
* Taking diuretic medication
* Living with heart failure
* Recovering from a coronary artery disease-related event
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180479 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180479: ReDS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180479
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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