510(k) · Cleared
ClearedFetal Doppler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Choice Electronic Technololgy Co., Ltd. · KNG Monitor, Ultrasonic, Fetal
Cleared on Oct 27, 2011 as substantially equivalent to K100626 (Shenzhen Biocare Electronics Co., Ltd., 2010) after a 24-day review. Its family tree reaches back 5 generations to 1994. 8 later devices descend from it.
- Decided
- Oct 27, 2011
- Review
- 24 days
- Class
- Class II
- Product code
- KNG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K930200 (1994). 8 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 backK082480 Contec Pocket Fetal DopplerContec Medical System Co., Ltd. · 2009
- 1 generation backK100626 Doppler Fetal Heart Rate Detector, Model FM-200Shenzhen Biocare Electronics Co., Ltd. · 2010
- This deviceK112911 Fetal DopplerBeijing Choice Electronic Technololgy Co., Ltd. · 2011
- Descendant · cites it directly · 6 of its ownK131457 Fetal Ultrasonic Monitor and AccessoriesShenzhen Jumper Medical Equipment Co., Ltd. · 2014
- Descendant · 2 generations on · 4 of its ownK182526 Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B…Vcomin Technology Limited · 2019
- Descendant · 3 generations on · 1 of its ownK220245 Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)Contec Medical Systems Co.,Ltd · 2022
- Descendant · 3 generations on · 1 of its ownK211940 Fetal DopplerShenzhen Taikang Medical Equipment Co., Ltd. · 2022
- Descendant · 4 generations on · 0 of its ownK252669 Fetal Doppler U8-25, U9-25Zhongshan Xiaolan Town Senlan Electronic Factory · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K131457Fetal Ultrasonic Monitor and AccessoriesShenzhen Jumper Medical Equipment Co., Ltd. · 2014 · cites it directly6descendants
- K182526Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B…Vcomin Technology Limited · 2019 · 2 generations on4descendants
- K220245Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)Contec Medical Systems Co.,Ltd · 2022 · 3 generations on1descendant
- K211940Fetal DopplerShenzhen Taikang Medical Equipment Co., Ltd. · 2022 · 3 generations on1descendant
- K252669Fetal Doppler U8-25, U9-25Zhongshan Xiaolan Town Senlan Electronic Factory · 2026 · 4 generations on0descendants
View 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 | K082480 | Contec Pocket Fetal Doppler | Contec Medical System Co., Ltd. | 2009 | — |
| −1 | K100626 | Doppler Fetal Heart Rate Detector, Model FM-200 | Shenzhen Biocare Electronics Co., Ltd. | 2010 | — |
| 0 (this device) | K112911 | Fetal Doppler | Beijing Choice Electronic Technololgy Co., Ltd. | 2011 | — |
| +1 | 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 | — |
| +3 | K220245 | Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) | Contec Medical Systems Co.,Ltd | 2022 | — |
| +3 | K211940 | Fetal Doppler | Shenzhen Taikang Medical Equipment Co., Ltd. | 2022 | — |
| +4 | K252669 | Fetal Doppler U8-25, U9-25 | Zhongshan Xiaolan Town Senlan Electronic Factory | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K100626 | Doppler Fetal Heart Rate Detector, Model FM-200Summary page 2…al Doppler is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats. 5. Predicate Device Identification 5 10(k) Number: K 100626 Product Name: Doppler Fetal Heart Rate Detector Manufacturer: Shenzhen Biocare Electronics Co., Ltd 6. Device Descr… | 2010 |
What descends from it? (8)
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 17 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K131457 (Shenzhen Jumper Medical Equipment Co., Ltd., 2014) has gone furthest, with 6 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. 2011, 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 a hand-held, battery powered audio Doppler device used for detecting fetal heart beats.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112911 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112911: Fetal Doppler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112911
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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