510(k) · Cleared
Recalled · 2010Doppler Needle and Flow Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Peripheral Systems Group · DPW Flowmeter, Blood, Cardiovascular
Cleared on Nov 7, 1990 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled once.
- Decided
- Nov 7, 1990
- Review
- 89 days
- Class
- Class II
- Product code
- DPW
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK903625 Doppler Needle and Flow MonitorPeripheral Systems Group · 1990
- Descendant · cites it directly · 2 of its ownK963989 P.D. Access (Percutaneous Doppler) Vascular Access DeviceCardiovascular Dynamics, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK973713 22 Gauge P.D. Access Vascular Access Device (Catheter/Needle…Cardiovascular Dynamics, Inc. · 1998
- Descendant · 2 generations on · 0 of its ownK090743 Yield Mini Doppler SystemBroncus Technologies, Inc. · 2009
Most influential descendants
Showing 3 of 3 · See all- K963989P.D. Access (Percutaneous Doppler) Vascular Access DeviceCardiovascular Dynamics, Inc. · 1997 · cites it directly2descendants
- K97371322 Gauge P.D. Access Vascular Access Device (Catheter/Needle Assembly), 24 Gauge P.D.…Cardiovascular Dynamics, Inc. · 1998 · cites it directly1descendant
- K090743Yield Mini Doppler SystemBroncus Technologies, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K903625 | Doppler Needle and Flow Monitor | Peripheral Systems Group | 1990 | — |
| +1 | K963989 | P.D. Access (Percutaneous Doppler) Vascular Access Device | Cardiovascular Dynamics, Inc. | 1997 | — |
| +1 | K973713 | 22 Gauge P.D. Access Vascular Access Device (Catheter/Needle Assembly), 24… | Cardiovascular Dynamics, Inc. | 1998 | — |
| +2 | K090743 | Yield Mini Doppler System | Broncus Technologies, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
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 |
|---|---|---|---|---|
| May 5, 2010 | Not classified | Z-0132-2011 | Package design/selection | The packaging of the vascular access device may potentially become damaged, compromising the sterility of the product. Use of a non-sterile product increases risk of patient infection. This recall involes: Model 78050 18 Gauge PD Access… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K963989 (Cardiovascular Dynamics, Inc., 1997) 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 | — |
https://510kreport.com/device/K903625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K903625: Doppler Needle and Flow Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K903625
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026