510(k) · Cleared
ClearedSD5 & SD6 Ultrasonic Tabletop 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 Jan 29, 2016 as substantially equivalent to K102138 (Edan Instruments, Inc., 2010) after a 58-day review. Its family tree reaches back 6 generations to 1994. 4 later devices descend from it.
- Decided
- Jan 29, 2016
- Review
- 58 days
- Class
- Class II
- Product code
- KNG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K930200 (1994). 10 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK930200 Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc. · 1994
- 5 generations backK991441 Cadence Doppler Ultrasound SystemMedasonics, Inc. · 1999
- 4 generations backK024197 Lifedop DopplerSummit Doppler Systems, Inc. · 2003 · Recalled
- 3 generations backK080087 Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite…Edan Instruments, Inc. · 2008
- 2 generations backK092997 Ultrasonic Tabletop Doppler, Models SD5 and SD6Edan Instruments, Inc. · 2009
- 1 generation backK102138 Ultrasonic Tabletop Doppler; Ultrasonic Tabletop DopplerEdan Instruments, Inc. · 2010
- This deviceK153475 SD5 & SD6 Ultrasonic Tabletop DopplerEdan Instruments, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK180419 Ultrasonic Doppler (Model YM-2T8)Shenzhen Imdk Medical Technology Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK212084 Fetal DopplerShenzhen Mericonn Technology Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK182710 Fetal Doppler, Model FD88Shenzzhen Luckcome Technology Inc., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK182190 Fetal DopplerShenzhen AOJ Medical Technology Co., Ltd. · 2018
Most influential descendants
Showing 4 of 4 · See all- K180419Ultrasonic Doppler (Model YM-2T8)Shenzhen Imdk Medical Technology Co., Ltd. · 2018 · cites it directly2descendants
- K212084Fetal DopplerShenzhen Mericonn Technology Co., Ltd. · 2021 · cites it directly0descendants
- K182710Fetal Doppler, Model FD88Shenzzhen Luckcome Technology Inc., Ltd. · 2019 · 2 generations on0descendants
- K182190Fetal DopplerShenzhen AOJ Medical Technology Co., Ltd. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930200 | Multi Dopplex II / Fetal Dopplex II | Huntleigh Healthcare, Inc. | 1994 | — |
| −5 | K991441 | Cadence Doppler Ultrasound System | Medasonics, Inc. | 1999 | — |
| −4 | K024197 | Lifedop Doppler | Summit Doppler Systems, Inc. | 2003 | 1 |
| −3 | 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 | — |
| −1 | K102138 | Ultrasonic Tabletop Doppler; Ultrasonic Tabletop Doppler | Edan Instruments, Inc. | 2010 | — |
| 0 (this device) | K153475 | SD5 & SD6 Ultrasonic Tabletop Doppler | Edan Instruments, Inc. | 2016 | — |
| +1 | K180419 | Ultrasonic Doppler (Model YM-2T8) | Shenzhen Imdk Medical Technology Co., Ltd. | 2018 | — |
| +1 | K212084 | Fetal Doppler | Shenzhen Mericonn Technology Co., Ltd. | 2021 | — |
| +2 | K182710 | Fetal Doppler, Model FD88 | Shenzzhen Luckcome Technology Inc., Ltd. | 2019 | — |
| +2 | K182190 | Fetal Doppler | Shenzhen AOJ Medical Technology Co., Ltd. | 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 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K102138 | Ultrasonic Tabletop Doppler; Ultrasonic Tabletop DopplerSummary page 10…atory Class: Class II 3. Reason for Technology Change. Submission 4. Predicate SD5&SD6 Ultrasonic Tabletop Doppler / K102138 / Edan Instruments, Inc. Device(s): The SD5&SD6 Ultrasonic Tabletop Doppler is a h… | 2010 |
| † | K150901 | Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express | 2015 |
What descends from it? (4)
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 22 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K180419 (Shenzhen Imdk Medical Technology Co., Ltd., 2018) has gone furthest, with 2 descendants 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. 2016, 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 SD5 Ultrasonic TableTop Doppler (hereinafter called “SD5”) and SD6 Ultrasonic TableTop Doppler (hereinafter called “SD6”) 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 obstetrical 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153475 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153475: SD5 & SD6 Ultrasonic Tabletop Doppler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153475
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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