510(k) · Cleared
ClearedSonotrax Ultrasonic Pocket Doppler
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 May 25, 2004 as substantially equivalent to K010889 (Huntleigh Healthcare, Inc., 2001) and 3 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1994. 21 later devices descend from it.
- Decided
- May 25, 2004
- Review
- 90 days
- Class
- Class II
- Product code
- KNG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K930200 (1994). 5 ancestors in all. 21 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK930200 Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc. · 1994
- 1 generation backK991441 Cadence Doppler Ultrasound SystemMedasonics, Inc. · 1999
- This deviceK040480 Sonotrax Ultrasonic Pocket DopplerEdan Instruments, Inc. · 2004
- Descendant · cites it directly · 13 of its ownK080087 Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite…Edan Instruments, Inc. · 2008
- Descendant · 2 generations on · 7 of its ownK092997 Ultrasonic Tabletop Doppler, Models SD5 and SD6Edan Instruments, Inc. · 2009
- Descendant · 2 generations on · 5 of its ownK102138 Ultrasonic Tabletop Doppler; Ultrasonic Tabletop DopplerEdan Instruments, Inc. · 2010
- Descendant · 3 generations on · 4 of its ownK153475 SD5 & SD6 Ultrasonic Tabletop DopplerEdan Instruments, Inc. · 2016
- Descendant · 2 generations on · 4 of its ownK101960 Sonotrax Series Ultrasonic Pocket DopplerEdan Instruments, Inc. · 2010
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K080087Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic, Pro, II, II…Edan Instruments, Inc. · 2008 · cites it directly13descendants
- K092997Ultrasonic Tabletop Doppler, Models SD5 and SD6Edan Instruments, Inc. · 2009 · 2 generations on7descendants
- K102138Ultrasonic Tabletop Doppler; Ultrasonic Tabletop DopplerEdan Instruments, Inc. · 2010 · 2 generations on5descendants
- K153475SD5 & SD6 Ultrasonic Tabletop DopplerEdan Instruments, Inc. · 2016 · 3 generations on4descendants
- K101960Sonotrax Series Ultrasonic Pocket DopplerEdan Instruments, Inc. · 2010 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930200 | Multi Dopplex II / Fetal Dopplex II | Huntleigh Healthcare, Inc. | 1994 | — |
| −1 | K991441 | Cadence Doppler Ultrasound System | Medasonics, Inc. | 1999 | — |
| 0 (this device) | K040480 | Sonotrax Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2004 | — |
| +1 | K080087 | Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic… | Edan Instruments, Inc. | 2008 | — |
| +2 | K092997 | Ultrasonic Tabletop Doppler, Models SD5 and SD6 | Edan Instruments, Inc. | 2009 | — |
| +2 | K102138 | Ultrasonic Tabletop Doppler; Ultrasonic Tabletop Doppler | Edan Instruments, Inc. | 2010 | — |
| +3 | K153475 | SD5 & SD6 Ultrasonic Tabletop Doppler | Edan Instruments, Inc. | 2016 | — |
| +2 | K101960 | Sonotrax Series Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 13.0 · 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? (4)
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 |
|---|---|---|---|
| * | K010889 | Baby Dopplex 3000 MK 2 (BD3000)Summary page 2…red By: Edan Instruments, Inc., China )NOT 0soNOTRAX 510K SUBMISSION 3. Predicate Devices: K010889, Baby Dopplex 3000MK 2, Huntleigh Healthcare Inc. UK. K991441, Cadence Doppler Ultrasound System, M… | 2001 |
| * | K991441 | Cadence Doppler Ultrasound SystemSummary page 2…3. Predicate Devices: K010889, Baby Dopplex 3000MK 2, Huntleigh Healthcare Inc. UK. K991441, Cadence Doppler Ultrasound System, Medasonics, Inc. K942441, Imexdop CT+, Imex Medical Systems, In… | 1999 |
| * | K942441 | Imexdop CT+Summary page 2…Dopplex 3000MK 2, Huntleigh Healthcare Inc. UK. K991441, Cadence Doppler Ultrasound System, Medasonics, Inc. K942441, Imexdop CT+, Imex Medical Systems, Inc. Golden, CO. K023618, Sonicaid One Fetal Heart Detector, UK… | 1994 |
| * | K023618 | Sonicaid OneSummary page 2…ence Doppler Ultrasound System, Medasonics, Inc. K942441, Imexdop CT+, Imex Medical Systems, Inc. Golden, CO. K023618, Sonicaid One Fetal Heart Detector, UK 4. Classification Names: Class II… | 2003 |
What descends from it? (21)
See all 215 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 10 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K080087 (Edan Instruments, Inc., 2008) has gone furthest, with 13 descendants of its own.
- 1 other device also cites its predicate K010889.
How does its category compare?
All KNG devicesKNG Monitor, Ultrasonic, Fetal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Detection of fetal heartbeat from early gestation thru delivery. Verify fetal heart viability after patient trauma. Display of fetal heart rate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040480 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040480: Sonotrax 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/K040480
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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