510(k) · Cleared
ClearedVolumeview System, Models VLV520FT6R, VLV520FT8R, VLV520FT6R5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · KRB Probe, Thermodilution
Cleared on Dec 7, 2010 as substantially equivalent to K072364 (Pulsion Medical Systems AG, 2007) and 1 other predicate after a 266-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.
- Decided
- Dec 7, 2010
- Review
- 266 days
- Class
- Class II
- Product code
- KRB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K935170 (1994). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK935170 Cardiovascular and Vascular Guidewire ModificationsLake Region Mfg., Inc. · 1994
- This deviceK100739 Volumeview System, Models VLV520FT6R, VLV520FT8R, VLV520FT6R5Edwards Lifesciences, LLC · 2010
- Descendant · cites it directly · 1 of its ownK110167 Presep Oligon Oximetry Catheters (16 CM, W/Heparin), (20CM, W/Heparin)Edwards Lifesciences, LLC · 2011
- Descendant · cites it directly · 0 of its ownK113565 Multi-Med Central Venous Catheters (CVCS), with and Without Heparin…Edwards Lifesciences, LLC · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935170 | Cardiovascular and Vascular Guidewire Modifications | Lake Region Mfg., Inc. | 1994 | — |
| 0 (this device) | K100739 | Volumeview System, Models VLV520FT6R, VLV520FT8R, VLV520FT6R5 | Edwards Lifesciences, LLC | 2010 | — |
| +1 | K110167 | Presep Oligon Oximetry Catheters (16 CM, W/Heparin), (20CM, W/Heparin) | Edwards Lifesciences, LLC | 2011 | — |
| +1 | K113565 | Multi-Med Central Venous Catheters (CVCS), with and Without Heparin Vantex… | Edwards Lifesciences, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 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 KRB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K072364 | Pulsion Pulsiocath Thermodilution Catheters & AccessoriesSummary page 1…Catheter Guidewire (21 CER 870.1330) Predicate Devices: Catheter: Pulsion Puilsiocath Thermiodilution Catheters & Accessories; cleared tinder K072364 Manifold: Pulsion Pulsiocath Thermodilution Catheters & Accessories; cleared under… | 2007 |
| * | K935170 | Cardiovascular and Vascular Guidewire ModificationsSummary page 1…Catheters & Accessories; cleared under K072364 Guidewire: Lake Region Mfg. Guidewire, cleared under K935 170 Device Description: The VolumeView System consists of a4 or 5 French, 16 or 20 cm, two lumen femoral ar… | 1994 |
What descends from it? (2)
2 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?
How does its category compare?
All KRB devicesKRB Probe, Thermodilution: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KRB
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · KRB
Too few KRB 510(k)s in any year since 2007 to give a median.
Recalls per year · KRB
3in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRB
6in 2025
MAUDE reports naming product code KRB, 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 | 1 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 8 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 15 |
| 2012 | 0 | — | 0 | 20 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 0 | 14 |
| 2015 | 0 | — | 0 | 45 |
| 2016 | 0 | — | 0 | 25 |
| 2017 | 0 | — | 0 | 24 |
| 2018 | 1 | — | 3 | 18 |
| 2019 | 0 | — | 0 | 26 |
| 2020 | 0 | — | 0 | 16 |
| 2021 | 0 | — | 0 | 22 |
| 2022 | 0 | — | 0 | 21 |
| 2023 | 0 | — | 0 | 13 |
| 2024 | 0 | — | 0 | 33 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VolumeView system is indicated for use in critical care patients in which cardio-respiratory function, fluid status, and vascular resistance need constant and/or intermittent assessment. The femoral arterial catheter is indicated for femoral artery insertion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100739 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100739: Volumeview System, Models VLV520FT6R, VLV520FT8R, VLV520FT6R5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100739
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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