510(k) · Cleared
ClearedUltrasonic 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 Feb 6, 2015 as substantially equivalent to K101960 (Edan Instruments, Inc., 2010) after a 337-day review. Its family tree reaches back 5 generations to 1994. 3 later devices descend from it.
- Decided
- Feb 6, 2015
- Review
- 337 days
- Class
- Class II
- Product code
- KNG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K930200 (1994). 9 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK930200 Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc. · 1994
- 4 generations backK991441 Cadence Doppler Ultrasound SystemMedasonics, Inc. · 1999
- 3 generations backK024197 Lifedop DopplerSummit Doppler Systems, Inc. · 2003 · Recalled
- 2 generations backK080087 Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite…Edan Instruments, Inc. · 2008
- 1 generation backK101960 Sonotrax Series Ultrasonic Pocket DopplerEdan Instruments, Inc. · 2010
- This deviceK140579 Ultrasonic Pocket DopplerEdan Instruments, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK191388 FloPatch (FP110)Flosonics Medical (R/A 1929803 Ontario Corp.) · 2019
- Descendant · 2 generations on · 0 of its ownK242487 Laminar P1 (LDH-HW-001)Laminar Digital Health, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK172780 SD1 Ultrasonic Pocket DopplerEdan Instruments, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930200 | Multi Dopplex II / Fetal Dopplex II | Huntleigh Healthcare, Inc. | 1994 | — |
| −4 | K991441 | Cadence Doppler Ultrasound System | Medasonics, Inc. | 1999 | — |
| −3 | K024197 | Lifedop Doppler | Summit Doppler Systems, Inc. | 2003 | 1 |
| −2 | K080087 | Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic… | Edan Instruments, Inc. | 2008 | — |
| −1 | K101960 | Sonotrax Series Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2010 | — |
| 0 (this device) | K140579 | Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2015 | — |
| +1 | K191388 | FloPatch (FP110) | Flosonics Medical (R/A 1929803 Ontario Corp.) | 2019 | — |
| +2 | K242487 | Laminar P1 (LDH-HW-001) | Laminar Digital Health, Inc. | 2024 | — |
| +1 | 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 |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K101960 | Sonotrax Series Ultrasonic Pocket DopplerSummary page 4…ot applicable, the subject device is Class II. Notification Class III Certification and Summary 4. Predicate Sonotrax Series Ultrasonic Pocket Doppler / K101960 / Edan Device(s): Instruments, Inc. The SD3 series Ultrasonic Pocket Doppler is a hand-hel… | 2010 |
What descends from it? (3)
2 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 21 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K191388 (Flosonics Medical (R/A 1929803 Ontario Corp.), 2019) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KNG devicesKNG Monitor, Ultrasonic, Fetal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 SD3 Series Ultrasonic Pocket Dopplers (hereinafter called “the Doppler”) are 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 waterproof probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a…
Read the full statement (135 words)
The SD3 Series Ultrasonic Pocket Dopplers (hereinafter called “the Doppler”) are 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 waterproof probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being. The 3 MHz waterproof probe is used for more than 9-week gestation and the 2 MHz is used for 12-week gestation. They can also be used to verify fetal heart viability.
The 4 MHz, 5 MHz and/or 8 MHz waterproof 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/K140579 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140579: Ultrasonic Pocket Doppler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140579
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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