510(k) · Cleared
ClearedFetal Doppler U8-25, U9-25
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhongshan Xiaolan Town Senlan Electronic Factory · KNG Monitor, Ultrasonic, Fetal
Cleared on Jan 8, 2026 as substantially equivalent to K211940 (Shenzhen Taikang Medical Equipment Co., Ltd., 2022) after a 136-day review. Its family tree reaches back 9 generations to 1994.
- Decided
- Jan 8, 2026
- Review
- 136 days
- Class
- Class II
- Product code
- KNG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K930200 (1994). No later device cites it as a predicate yet.
- Root · 9 generations backK930200 Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc. · 1994
- 5 generations between
- 3 generations backK131457 Fetal Ultrasonic Monitor and AccessoriesShenzhen Jumper Medical Equipment Co., Ltd. · 2014
- 2 generations backK182526 Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B…Vcomin Technology Limited · 2019
- 1 generation backK211940 Fetal DopplerShenzhen Taikang Medical Equipment Co., Ltd. · 2022
- This deviceK252669 Fetal Doppler U8-25, U9-25Zhongshan Xiaolan Town Senlan Electronic Factory · 2026
Show all 9 generations
- Root · 9 generations backK930200 Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc. · 1994
- 8 generations backK991441 Cadence Doppler Ultrasound SystemMedasonics, Inc. · 1999
- 7 generations backK024197 Lifedop DopplerSummit Doppler Systems, Inc. · 2003 · Recalled
- 6 generations backK082480 Contec Pocket Fetal DopplerContec Medical System Co., Ltd. · 2009
- 5 generations backK100626 Doppler Fetal Heart Rate Detector, Model FM-200Shenzhen Biocare Electronics Co., Ltd. · 2010
- 4 generations backK112911 Fetal DopplerBeijing Choice Electronic Technololgy Co., Ltd. · 2011
- 3 generations backK131457 Fetal Ultrasonic Monitor and AccessoriesShenzhen Jumper Medical Equipment Co., Ltd. · 2014
- 2 generations backK182526 Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B…Vcomin Technology Limited · 2019
- 1 generation backK211940 Fetal DopplerShenzhen Taikang Medical Equipment Co., Ltd. · 2022
- This deviceK252669 Fetal Doppler U8-25, U9-25Zhongshan Xiaolan Town Senlan Electronic Factory · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K930200 | Multi Dopplex II / Fetal Dopplex II | Huntleigh Healthcare, Inc. | 1994 | — |
| −8 | K991441 | Cadence Doppler Ultrasound System | Medasonics, Inc. | 1999 | — |
| −7 | K024197 | Lifedop Doppler | Summit Doppler Systems, Inc. | 2003 | 1 |
| −6 | K082480 | Contec Pocket Fetal Doppler | Contec Medical System Co., Ltd. | 2009 | — |
| −5 | K100626 | Doppler Fetal Heart Rate Detector, Model FM-200 | Shenzhen Biocare Electronics Co., Ltd. | 2010 | — |
| −4 | K112911 | Fetal Doppler | Beijing Choice Electronic Technololgy Co., Ltd. | 2011 | — |
| −3 | K131457 | Fetal Ultrasonic Monitor and Accessories | Shenzhen Jumper Medical Equipment Co., Ltd. | 2014 | — |
| −2 | K182526 | Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D… | Vcomin Technology Limited | 2019 | — |
| −1 | K211940 | Fetal Doppler | Shenzhen Taikang Medical Equipment Co., Ltd. | 2022 | — |
| 0 (this device) | K252669 | Fetal Doppler U8-25, U9-25 | Zhongshan Xiaolan Town Senlan Electronic Factory | 2026 | — |
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 K242846 Doppler FHR Detector (BF-500D+, BF-560)score 10.5 · 4 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 |
|---|---|---|---|
| * | K211940 | Fetal DopplerSummary page 6…Page 2 of 7 Product code: KNG (Monitor, Ultrasonic, Fetal) Classification Panel: Obstetrics/Gynecology Device Class: II 4. Predicate Device 510(k) Number: K211940 Device Name: Fetal Doppler, Model TK-T802CR Manufacturer: Shenzhen Taikang Medical Equipment Co., Ltd., The predicate device ha… | 2022 |
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 32 years and passes through 10 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 9 ancestors has a recall of any class.
How does its category compare?
All KNG devicesKNG Monitor, Ultrasonic, Fetal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Fetal Doppler is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in hospital, clinic, community and home. The device is intended for use at or after 16 weeks gestation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252669 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252669: Fetal Doppler U8-25, U9-25.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252669
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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