510(k) · Cleared
ClearedSonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic, Pro, II, II Pro and Vascular
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edan Instruments, Inc. · KNG Monitor, Ultrasonic, Fetal
Cleared on Mar 11, 2008 as substantially equivalent to K040480 (Edan Instruments, Inc., 2004) and 1 other predicate after a 60-day review. Its family tree reaches back 3 generations to 1994. 13 later devices descend from it.
- Decided
- Mar 11, 2008
- Review
- 60 days
- Class
- Class II
- Product code
- KNG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K930200 (1994). 7 ancestors in all. 13 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK930200 Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc. · 1994
- 2 generations backK991441 Cadence Doppler Ultrasound SystemMedasonics, Inc. · 1999
- 1 generation backK024197 Lifedop DopplerSummit Doppler Systems, Inc. · 2003 · Recalled
- This deviceK080087 Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite…Edan Instruments, Inc. · 2008
- Descendant · cites it directly · 7 of its ownK092997 Ultrasonic Tabletop Doppler, Models SD5 and SD6Edan Instruments, Inc. · 2009
- Descendant · cites it directly · 5 of its ownK102138 Ultrasonic Tabletop Doppler; Ultrasonic Tabletop DopplerEdan Instruments, Inc. · 2010
- Descendant · 2 generations on · 4 of its ownK153475 SD5 & SD6 Ultrasonic Tabletop DopplerEdan Instruments, Inc. · 2016
- Descendant · cites it directly · 4 of its ownK101960 Sonotrax Series Ultrasonic Pocket DopplerEdan Instruments, Inc. · 2010
- Descendant · 2 generations on · 3 of its ownK140579 Ultrasonic Pocket DopplerEdan Instruments, Inc. · 2015
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K092997Ultrasonic Tabletop Doppler, Models SD5 and SD6Edan Instruments, Inc. · 2009 · cites it directly7descendants
- K102138Ultrasonic Tabletop Doppler; Ultrasonic Tabletop DopplerEdan Instruments, Inc. · 2010 · cites it directly5descendants
- K153475SD5 & SD6 Ultrasonic Tabletop DopplerEdan Instruments, Inc. · 2016 · 2 generations on4descendants
- K101960Sonotrax Series Ultrasonic Pocket DopplerEdan Instruments, Inc. · 2010 · cites it directly4descendants
- K140579Ultrasonic Pocket DopplerEdan Instruments, Inc. · 2015 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930200 | Multi Dopplex II / Fetal Dopplex II | Huntleigh Healthcare, Inc. | 1994 | — |
| −2 | K991441 | Cadence Doppler Ultrasound System | Medasonics, Inc. | 1999 | — |
| −1 | K024197 | Lifedop Doppler | Summit Doppler Systems, Inc. | 2003 | 1 |
| 0 (this device) | K080087 | Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic… | Edan Instruments, Inc. | 2008 | — |
| +1 | K092997 | Ultrasonic Tabletop Doppler, Models SD5 and SD6 | Edan Instruments, Inc. | 2009 | — |
| +1 | K102138 | Ultrasonic Tabletop Doppler; Ultrasonic Tabletop Doppler | Edan Instruments, Inc. | 2010 | — |
| +2 | K153475 | SD5 & SD6 Ultrasonic Tabletop Doppler | Edan Instruments, Inc. | 2016 | — |
| +1 | K101960 | Sonotrax Series Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2010 | — |
| +2 | K140579 | Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2015 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2021 | 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 KNG? 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 KNG device
- #1 K252669 Fetal Doppler U8-25, U9-25score 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K040480 | Sonotrax Ultrasonic Pocket DopplerSummary page 2…Product Code: KNG HEP Manufactured By: Edan Instruments, Inc., China 3. Predicate Devices: K040480 Sonotrax Ultrasonic Pocket Doppler, manufactured by Edan Instruments, Inc. K024197 LifeDop Doppler Ultrasound System, man… | 2004 |
| * | K024197 | Lifedop DopplerSummary page 2…ed By: Edan Instruments, Inc., China 3. Predicate Devices: K040480 Sonotrax Ultrasonic Pocket Doppler, manufactured by Edan Instruments, Inc. K024197 LifeDop Doppler Ultrasound System, manufactured by Summit Doppler Systems, 5350 Vivian St., Suite A, Arvada, CO 80002… | 2003 |
What descends from it? (13)
See all 133 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)
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 14 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K092997 (Edan Instruments, Inc., 2009) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K040480.
How does its category compare?
All KNG devicesKNG Monitor, Ultrasonic, Fetal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KNG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNG
202in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNG
No recall names KNG since 2007.
Adverse event reports per year · KNG
1in 2025
MAUDE reports naming product code KNG, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 3 | 181 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 5 | 57 | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 3 | 154 | 0 | 8 |
| 2019 | 3 | 202 | 0 | 1 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 2 | — | 0 | 3 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The 2 mHz and/ or 3 mHz obstetrical probes are
indicated for the detection of fetal life from early
gestation thru delivery. They can also be used to
verify fetal heart viability.
The 4 mHz and/ or 8 mHz vascular probes are
indicated for the detection of blood flow in veins and
arteries for assisting in the detection of peripheral
vascular disease.
The Sonotrax series of pocket dopplers are to be used
by health care professionals including registered
nurses, practical nurses, midwives, ultrasound
technicians, and physicians assistants, by
prescription from licensed physicians in hospitals,
clinics and private offices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080087 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080087: Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic, Pro, II, II Pro and Vascular.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080087
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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