510(k) · Cleared
ClearedSD1 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 Jun 6, 2018 as substantially equivalent to K131457 (Shenzhen Jumper Medical Equipment Co., Ltd., 2014) and 1 other predicate after a 265-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Jun 6, 2018
- Review
- 265 days
- Class
- Class II
- Product code
- KNG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K930200 (1994). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK930200 Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc. · 1994
- 6 generations backK991441 Cadence Doppler Ultrasound SystemMedasonics, Inc. · 1999
- 5 generations backK024197 Lifedop DopplerSummit Doppler Systems, Inc. · 2003 · Recalled
- 4 generations backK082480 Contec Pocket Fetal DopplerContec Medical System Co., Ltd. · 2009
- 3 generations backK100626 Doppler Fetal Heart Rate Detector, Model FM-200Shenzhen Biocare Electronics Co., Ltd. · 2010
- 2 generations backK112911 Fetal DopplerBeijing Choice Electronic Technololgy Co., Ltd. · 2011
- 1 generation backK131457 Fetal Ultrasonic Monitor and AccessoriesShenzhen Jumper Medical Equipment Co., Ltd. · 2014
- This deviceK172780 SD1 Ultrasonic Pocket DopplerEdan Instruments, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K930200 | Multi Dopplex II / Fetal Dopplex II | Huntleigh Healthcare, Inc. | 1994 | — |
| −6 | K991441 | Cadence Doppler Ultrasound System | Medasonics, Inc. | 1999 | — |
| −5 | K024197 | Lifedop Doppler | Summit Doppler Systems, Inc. | 2003 | 1 |
| −4 | K082480 | Contec Pocket Fetal Doppler | Contec Medical System Co., Ltd. | 2009 | — |
| −3 | K100626 | Doppler Fetal Heart Rate Detector, Model FM-200 | Shenzhen Biocare Electronics Co., Ltd. | 2010 | — |
| −2 | K112911 | Fetal Doppler | Beijing Choice Electronic Technololgy Co., Ltd. | 2011 | — |
| −1 | K131457 | Fetal Ultrasonic Monitor and Accessories | Shenzhen Jumper Medical Equipment Co., Ltd. | 2014 | — |
| 0 (this device) | 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 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 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? (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 |
|---|---|---|---|
| * | K131457 | Fetal Ultrasonic Monitor and AccessoriesSummary page 4…ic monitor and accessories Product code: KNG (monitor, ultrasonic, fetal) Regulatory Class: Class II 1. K131457, FETAL ULTRASONIC MONITOR AND ACCESSORIES /JPD- 3. Predicate 100B, Shenzhen Jumper Medical Equipment Co. (Primary) Devic… | 2014 |
| * | K140579 | Ultrasonic Pocket DopplerSummary page 4…1. K131457, FETAL ULTRASONIC MONITOR AND ACCESSORIES /JPD- 3. Predicate 100B, Shenzhen Jumper Medical Equipment Co. (Primary) Device(s): 2. K140579, SD3 ULTRASONIC POCKET DOPPLER, Edan Instruments, Inc. (Secondary) The predicate dev… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 8 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 14 ancestors has a recall of any class.
- 1 other device also cites its predicate K131457.
How does its category compare?
All KNG devicesKNG Monitor, Ultrasonic, Fetal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 SD1 is a pocket Doppler device used for detecting the fetal heartbeat from the 10th week of gestation. It is intended to be used by medical professionals only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172780 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172780: SD1 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/K172780
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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