510(k) · Cleared
ClearedAngioflow Meter, Angioflow Antegrade Catheter, Angioflow Retrograde Catheter, Models HVT100, ADT1001, ADT1002
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Transonic Systems, Inc. · DPW Flowmeter, Blood, Cardiovascular
Cleared on Dec 11, 2003 as substantially equivalent to K010253 (Transonic Systems, Inc., 2002) after a 49-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Dec 11, 2003
- Review
- 49 days
- Class
- Class II
- Product code
- DPW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010253 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK010253 Angio Flow Thermodilution Catheter, Model AF-Cath-01; Angioflow…Transonic Systems, Inc. · 2002
- This deviceK033424 Angioflow Meter, Angioflow Antegrade Catheter, Angioflow Retrograde…Transonic Systems, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010253 | Angio Flow Thermodilution Catheter, Model AF-Cath-01; Angioflow Meter, Models… | Transonic Systems, Inc. | 2002 | — |
| 0 (this device) | K033424 | Angioflow Meter, Angioflow Antegrade Catheter, Angioflow Retrograde Catheter… | Transonic Systems, Inc. | 2003 | — |
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? (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 |
|---|---|---|---|
| * | K010253 | Angio Flow Thermodilution Catheter, Model AF-Cath-01; Angioflow Meter, Models HQ100 and…Summary page 1…21 CRF §870.2100 SUBSTANTIAL EQUIVALENCE TO: 510 (k) Number Name Applicant K010253 Transonic Anglo Transonic Systems Inc. Flow Meter and… | 2002 |
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?
- Its one ancestor has no recall.
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?
The Transonic AngioFlow meter and catheter are indicated for use during angioplasty procedures to verify the flow before, during, and after treatment. The system is intended for the measurement of blood flow within a vascular bed utilizing a catheter-based sensor. This sensor system uses thermal changes induced by a bolus injection of normal saline and thermal-dilution principles to calculate blood flow.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033424 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033424: Angioflow Meter, Angioflow Antegrade Catheter, Angioflow Retrograde Catheter, Models HVT100, ADT1001, ADT1002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033424
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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