510(k) · Cleared
ClearedSonotrax Series Ultrasonic Pocket Doppler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edan Instruments, Inc. · HEP Monitor, Blood-Flow, Ultrasonic
Cleared on Aug 10, 2010 as substantially equivalent to K080087 (Edan Instruments, Inc., 2008) after a 29-day review. Its family tree reaches back 4 generations to 1994. 4 later devices descend from it.
- Decided
- Aug 10, 2010
- Review
- 29 days
- Class
- Class II
- Product code
- HEP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K930200 (1994). 8 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK930200 Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc. · 1994
- 3 generations backK991441 Cadence Doppler Ultrasound SystemMedasonics, Inc. · 1999
- 2 generations backK024197 Lifedop DopplerSummit Doppler Systems, Inc. · 2003 · Recalled
- 1 generation backK080087 Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite…Edan Instruments, Inc. · 2008
- This deviceK101960 Sonotrax Series Ultrasonic Pocket DopplerEdan Instruments, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK140579 Ultrasonic Pocket DopplerEdan Instruments, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK191388 FloPatch (FP110)Flosonics Medical (R/A 1929803 Ontario Corp.) · 2019
- Descendant · 3 generations on · 0 of its ownK242487 Laminar P1 (LDH-HW-001)Laminar Digital Health, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK172780 SD1 Ultrasonic Pocket DopplerEdan Instruments, Inc. · 2018
Most influential descendants
Showing 4 of 4 · See all- K140579Ultrasonic Pocket DopplerEdan Instruments, Inc. · 2015 · cites it directly3descendants
- K191388FloPatch (FP110)Flosonics Medical (R/A 1929803 Ontario Corp.) · 2019 · 2 generations on1descendant
- K242487Laminar P1 (LDH-HW-001)Laminar Digital Health, Inc. · 2024 · 3 generations on0descendants
- K172780SD1 Ultrasonic Pocket DopplerEdan Instruments, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930200 | Multi Dopplex II / Fetal Dopplex II | Huntleigh Healthcare, Inc. | 1994 | — |
| −3 | K991441 | Cadence Doppler Ultrasound System | Medasonics, Inc. | 1999 | — |
| −2 | K024197 | Lifedop Doppler | Summit Doppler Systems, Inc. | 2003 | 1 |
| −1 | K080087 | Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic… | Edan Instruments, Inc. | 2008 | — |
| 0 (this device) | K101960 | Sonotrax Series Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2010 | — |
| +1 | K140579 | Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2015 | — |
| +2 | K191388 | FloPatch (FP110) | Flosonics Medical (R/A 1929803 Ontario Corp.) | 2019 | — |
| +3 | K242487 | Laminar P1 (LDH-HW-001) | Laminar Digital Health, Inc. | 2024 | — |
| +2 | K172780 | SD1 Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 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 HEP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K080087 | Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic, Pro, II, II…Summary page 1…DOPPLER Manufacturer Edan Instruments, Inc K# K080087 Device Description: The Sonotrax series Ultrasonic Pocket Doppler is a hand-held device… | 2008 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140579 | Ultrasonic Pocket Doppler | 2015 | 3 |
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 16 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K140579 (Edan Instruments, Inc., 2015) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K080087.
How does its category compare?
All HEP devicesHEP Monitor, Blood-Flow, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · HEP
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · HEP
Too few HEP 510(k)s in any year since 2007 to give a median.
Recalls per year · HEP
No recall names HEP since 2007.
Adverse event reports per year · HEP
No MAUDE report names HEP since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Sonotrax Series Ultrasonic Pocket Doppler is intended to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices. The 2 MHz and/or 3 MHz probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being.…
Read the full statement (111 words)
The Sonotrax Series Ultrasonic Pocket Doppler is intended to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices.
The 2 MHz and/or 3 MHz probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being. They can also be used to verify fetal heart viability following patient trauma.
The 4 MHz, 5 MHz and/or 8 MLHz vascular probes are indicated for the detection of blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101960 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101960: Sonotrax Series Ultrasonic Pocket Doppler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101960
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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