510(k) · Cleared
ClearedFlowguard Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosonix, Ltd. · DPW Flowmeter, Blood, Cardiovascular
Cleared on Feb 13, 2002 as substantially equivalent to K892707 (Koven and Assoc., Inc., 1989) and 2 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1985. 4 later devices descend from it.
- Decided
- Feb 13, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- DPW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K851426 (1985). 8 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK851426 Accucom Cardiac Output MonitorLawrence Medical Systems, Inc. · 1985
- 1 generation backK972798 Dynemo 3000Sometec, Inc. · 1998
- This deviceK013803 Flowguard DeviceBiosonix, Ltd. · 2002
- Descendant · cites it directly · 2 of its ownK030357 Quantix/or DeviceCardiosonix, Ltd. · 2003 · Recalled
- Descendant · 2 generations on · 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
- Descendant · cites it directly · 0 of its ownK023431 Quantix/ND DeviceCardiosonix, Ltd. · 2002
Most influential descendants
Showing 4 of 4 · See all- K030357Quantix/or DeviceCardiosonix, Ltd. · 2003 · cites it directly2descendants
- K041180Quantix or Vessel Stabilizer DeviceCardiosonix, Ltd. · 2004 · 2 generations on1descendant
- K050088Quantix/or Blood Flow Monitor; Flexible Probe with Optional Vessel StabilizerNeoprobe Corp. · 2005 · cites it directly0descendants
- K023431Quantix/ND DeviceCardiosonix, Ltd. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K851426 | Accucom Cardiac Output Monitor | Lawrence Medical Systems, Inc. | 1985 | — |
| −1 | K972798 | Dynemo 3000 | Sometec, Inc. | 1998 | — |
| 0 (this device) | K013803 | Flowguard Device | Biosonix, Ltd. | 2002 | — |
| +1 | K030357 | Quantix/or Device | Cardiosonix, Ltd. | 2003 | 2 |
| +2 | 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 | — |
| +1 | K023431 | Quantix/ND Device | Cardiosonix, Ltd. | 2002 | — |
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 |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 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 13.7 · 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? (3)
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 |
|---|---|---|---|
| * | K892707 | DVM-4200 Blood FlowmeterSummary page 1…ard device is substantially equivalent to a combination of the following devices: Device Manufacturer 510(k) No. Blood Flow Meter Model HD-4200 Koven Technology, Inc. | K892707 EchoFlow BVM-1 EchoCath Inc. K990642 Dynemo 3000 Sometec Inc. K972798 358 4, Intended Use The FlowGuard device… | 1989 |
| * | K990642 | Echoflow Doppler Blood Velocity MeterSummary page 1…t to a combination of the following devices: Device Manufacturer 510(k) No. Blood Flow Meter Model HD-4200 Koven Technology, Inc. | K892707 EchoFlow BVM-1 EchoCath Inc. K990642 Dynemo 3000 Sometec Inc. K972798 358 4, Intended Use The FlowGuard device is intended for non-invasive, periphe… | 1999 |
| * | K972798 | Dynemo 3000Summary page 1…ng devices: Device Manufacturer 510(k) No. Blood Flow Meter Model HD-4200 Koven Technology, Inc. | K892707 EchoFlow BVM-1 EchoCath Inc. K990642 Dynemo 3000 Sometec Inc. K972798 358 4, Intended Use The FlowGuard device is intended for non-invasive, peripheral vessel examinations and intr… | 1998 |
What descends from it? (4)
3 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?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 12.6 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K030357 (Cardiosonix, Ltd., 2003) has gone furthest, with 2 descendants of its own.
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
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/K013803 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013803: Flowguard Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013803
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026