510(k) · Cleared
Recalled · 2004Quantix/or Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiosonix, Ltd. · DPW Flowmeter, Blood, Cardiovascular
Cleared on Aug 20, 2003 as substantially equivalent to K013803 (Biosonix, Ltd., 2002) after a 198-day review. Its family tree reaches back 3 generations to 1985. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 20, 2003
- Review
- 198 days
- Class
- Class II
- Product code
- DPW
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K851426 (1985). 9 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK851426 Accucom Cardiac Output MonitorLawrence Medical Systems, Inc. · 1985
- 2 generations backK972798 Dynemo 3000Sometec, Inc. · 1998
- 1 generation backK013803 Flowguard DeviceBiosonix, Ltd. · 2002
- This deviceK030357 Quantix/or DeviceCardiosonix, Ltd. · 2003
- Descendant · cites it directly · 1 of its ownK041180 Quantix or Vessel Stabilizer DeviceCardiosonix, Ltd. · 2004
- Descendant · cites it directly · 0 of its ownK050088 Quantix/or Blood Flow Monitor; Flexible Probe with Optional Vessel…Neoprobe Corp. · 2005
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 |
|---|---|---|---|---|---|
| −3 | K851426 | Accucom Cardiac Output Monitor | Lawrence Medical Systems, Inc. | 1985 | — |
| −2 | K972798 | Dynemo 3000 | Sometec, Inc. | 1998 | — |
| −1 | K013803 | Flowguard Device | Biosonix, Ltd. | 2002 | — |
| 0 (this device) | K030357 | Quantix/or Device | Cardiosonix, Ltd. | 2003 | — |
| +1 | K041180 | Quantix or Vessel Stabilizer Device | Cardiosonix, Ltd. | 2004 | — |
| +1 | K050088 | Quantix/or Blood Flow Monitor; Flexible Probe with Optional Vessel Stabilizer | Neoprobe Corp. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 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 DPW? 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 DPW device
- #1 K251114 FloPatch FP120score 13.8 · 5 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 |
|---|---|---|---|
| * | K013803 | Flowguard Device | 2002 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 13, 2004 | Not classified | Z-0700-05 | Other | The probe's faceplate seal can fail and allow penetration of cleaning fluids during the cleaning and soaking cycle between uses or ingress of biohazard fluids during surgical procedures. |
| Dec 13, 2004 | Not classified | Z-0701-05 | Other | The probe's faceplate seal can fail and allow penetration of cleaning fluids during the cleaning and soaking cycle between uses or ingress of biohazard fluids during surgical procedures. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K041180 (Cardiosonix, Ltd., 2004) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K013803.
How does its category compare?
All DPW devicesDPW Flowmeter, Blood, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DPW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPW
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPW
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DPW
6in 2025
MAUDE reports naming product code DPW, 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 | — | 4 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 2 | — | 1 | 0 |
| 2011 | 4 | 89 | 0 | 1 |
| 2012 | 1 | — | 1 | 0 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 3 | 275 | 0 | 12 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 3 | 169 | 0 | 3 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 3 | 136 | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 3 | 119 | 1 | 6 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Diagnostic blood flow measurements
Intra-operative: For direct application to exposed blood vessel (miniature, sterilizable transducer)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030357 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030357: Quantix/or Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030357
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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