510(k) · Cleared
ClearedUltramed TF 122 Ultrason Vascu Imag & Doppler Syst
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultramed, Inc. · JOP Transducer, Ultrasonic
Cleared on Jul 7, 1986 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Jul 7, 1986
- Review
- 84 days
- Class
- Class II
- Product code
- JOP
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK861378 Ultramed TF 122 Ultrason Vascu Imag & Doppler SystUltramed, Inc. · 1986
- Descendant · cites it directly · 5 of its ownK990642 Echoflow Doppler Blood Velocity MeterEchocath, Inc. · 1999
- Descendant · 2 generations on · 4 of its ownK013803 Flowguard DeviceBiosonix, Ltd. · 2002
- Descendant · 3 generations on · 2 of its ownK030357 Quantix/or DeviceCardiosonix, Ltd. · 2003 · Recalled
- Descendant · 4 generations on · 1 of its ownK041180 Quantix or Vessel Stabilizer DeviceCardiosonix, Ltd. · 2004
- Descendant · 3 generations on · 0 of its ownK050088 Quantix/or Blood Flow Monitor; Flexible Probe with Optional Vessel…Neoprobe Corp. · 2005
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K990642Echoflow Doppler Blood Velocity MeterEchocath, Inc. · 1999 · cites it directly5descendants
- K013803Flowguard DeviceBiosonix, Ltd. · 2002 · 2 generations on4descendants
- K030357Quantix/or DeviceCardiosonix, Ltd. · 2003 · 3 generations on2descendants
- K041180Quantix or Vessel Stabilizer DeviceCardiosonix, Ltd. · 2004 · 4 generations on1descendant
- K050088Quantix/or Blood Flow Monitor; Flexible Probe with Optional Vessel StabilizerNeoprobe Corp. · 2005 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K861378 | Ultramed TF 122 Ultrason Vascu Imag & Doppler Syst | Ultramed, Inc. | 1986 | — |
| +1 | K990642 | Echoflow Doppler Blood Velocity Meter | Echocath, Inc. | 1999 | — |
| +2 | K013803 | Flowguard Device | Biosonix, Ltd. | 2002 | — |
| +3 | K030357 | Quantix/or Device | Cardiosonix, Ltd. | 2003 | 2 |
| +4 | K041180 | Quantix or Vessel Stabilizer Device | Cardiosonix, Ltd. | 2004 | — |
| +3 | K050088 | Quantix/or Blood Flow Monitor; Flexible Probe with Optional Vessel Stabilizer | Neoprobe Corp. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990642 | Echoflow Doppler Blood Velocity Meter | 1999 | 5 |
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?
- Of its descendants, K990642 (Echocath, Inc., 1999) has gone furthest, with 5 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 | — |
https://510kreport.com/device/K861378 · printed Nov 6, 2026
Cite this page
510(k) Report. “K861378: Ultramed TF 122 Ultrason Vascu Imag & Doppler Syst.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K861378
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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