510(k) · Cleared
ClearedEchoflow Doppler Blood Velocity Meter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Echocath, Inc. · JOP Transducer, Ultrasonic
Cleared on Sep 16, 1999 as substantially equivalent to K861378 (Ultramed, Inc., 1986) and 1 other predicate after a 202-day review. Its family tree reaches back 1 generation to 1986. 5 later devices descend from it.
- Decided
- Sep 16, 1999
- Review
- 202 days
- Class
- Class II
- Product code
- JOP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K861378 (1986). 2 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK861378 Ultramed TF 122 Ultrason Vascu Imag & Doppler SystUltramed, Inc. · 1986
- This deviceK990642 Echoflow Doppler Blood Velocity MeterEchocath, Inc. · 1999
- Descendant · cites it directly · 4 of its ownK013803 Flowguard DeviceBiosonix, Ltd. · 2002
- Descendant · 2 generations on · 2 of its ownK030357 Quantix/or DeviceCardiosonix, Ltd. · 2003 · Recalled
- Descendant · 3 generations on · 1 of its ownK041180 Quantix or Vessel Stabilizer DeviceCardiosonix, Ltd. · 2004
- Descendant · 2 generations on · 0 of its ownK050088 Quantix/or Blood Flow Monitor; Flexible Probe with Optional Vessel…Neoprobe Corp. · 2005
- Descendant · 2 generations on · 0 of its ownK023431 Quantix/ND DeviceCardiosonix, Ltd. · 2002
Most influential descendants
Showing 5 of 5 · See all- K013803Flowguard DeviceBiosonix, Ltd. · 2002 · cites it directly4descendants
- K030357Quantix/or DeviceCardiosonix, Ltd. · 2003 · 2 generations on2descendants
- K041180Quantix or Vessel Stabilizer DeviceCardiosonix, Ltd. · 2004 · 3 generations on1descendant
- K050088Quantix/or Blood Flow Monitor; Flexible Probe with Optional Vessel StabilizerNeoprobe Corp. · 2005 · 2 generations on0descendants
- K023431Quantix/ND DeviceCardiosonix, Ltd. · 2002 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K861378 | Ultramed TF 122 Ultrason Vascu Imag & Doppler Syst | Ultramed, Inc. | 1986 | — |
| 0 (this device) | K990642 | Echoflow Doppler Blood Velocity Meter | Echocath, Inc. | 1999 | — |
| +1 | K013803 | Flowguard Device | Biosonix, Ltd. | 2002 | — |
| +2 | K030357 | Quantix/or Device | Cardiosonix, Ltd. | 2003 | 2 |
| +3 | K041180 | Quantix or Vessel Stabilizer Device | Cardiosonix, Ltd. | 2004 | — |
| +2 | K050088 | Quantix/or Blood Flow Monitor; Flexible Probe with Optional Vessel Stabilizer | Neoprobe Corp. | 2005 | — |
| +2 | K023431 | Quantix/ND Device | Cardiosonix, Ltd. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 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 JOP? 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 JOP device
- #1 K242662 Falcon/Xpress (Falcon/Xpress)score 8.8 · 2 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K861378 | Ultramed TF 122 Ultrason Vascu Imag & Doppler SystSummary page 1…ood-flow measuring system Classification Name: Flowmeter, blood, ultrasonic, w/wo calibration, and Transducer, Ultrasonic (3) Predicate devices: 1. Ultramed Ultraplex, K861378 2. Zertl K921377, P/Meter (4) Description The EchoFlow velocity system is a computer-based ultrasonic Doppler blood velocity me… | 1986 |
| * | K921377 | P/MeterSummary page 1…g system Classification Name: Flowmeter, blood, ultrasonic, w/wo calibration, and Transducer, Ultrasonic (3) Predicate devices: 1. Ultramed Ultraplex, K861378 2. Zertl K921377, P/Meter (4) Description The EchoFlow velocity system is a computer-based ultrasonic Doppler blood velocity measuring system us… | 1993 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013803 | Flowguard Device | 2002 | 4 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K013803 (Biosonix, Ltd., 2002) has gone furthest, with 4 descendants of its own.
How does its category compare?
All JOP devicesJOP Transducer, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JOP
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JOP
Too few JOP 510(k)s in any year since 2007 to give a median.
Recalls per year · JOP
No recall names JOP since 2007.
Adverse event reports per year · JOP
2in 2025
MAUDE reports naming product code JOP, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EchoFlow BVM-1 is an ultrasonic Doppler system that can be used to measure blood flow velocities. It can be used either for measurement of vessels below the skin, or for intraoperative measurements. It is not intended for cardiac or fetal use. A 10 MHz probe is supplied. The unit maintains its specified accuracy even if the angle between the probe face and vessel axis is as much as £15°, unlike conventional Doppler systems where the angle between the…
Read the full statement (263 words)
The EchoFlow BVM-1 is an ultrasonic Doppler system that can be used to measure blood flow velocities. It can be used either for measurement of vessels below the skin, or for intraoperative measurements. It is not intended for cardiac or fetal use. A 10 MHz probe is supplied. The unit maintains its specified accuracy even if the angle between the probe face and vessel axis is as much as £15°, unlike conventional Doppler systems where the angle between the flow direction and the probe must be accurately known. The unit can detect large blood vessels at depths up to 12 mm and small blood vessels at depths up to 10 mm in normal tissue. The system will not detect any signals from vessels more than 15.5 mm from the probe.
The IOP10 transducer for the EchoFlow BVM-1 is intended to be used with that unit to measure blood flow velocities. It can be used either for measurement of vessels below the skin, or for intraoperative measurements. It is not intended for cardiac or fetal use. A 10 MHz probe is supplied. The unit maintains its specified accuracy even if the angle between the probe face and vessel axis is as much as +15°, unlike conventional Doppler systems where the angle between the flow direction and the probe must be accurately known. The unit can detect large blood vessels at depths up to 12 mm and small blood vessels at depths up to 10 mm in normal tissue. The system will not detect any signals from vessels more than 15.5 mm from the probe.
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/K990642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990642: Echoflow Doppler Blood Velocity Meter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990642
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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