510(k) · Cleared
ClearedFetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vcomin Technology Limited · KNG Monitor, Ultrasonic, Fetal
Cleared on May 29, 2019 as substantially equivalent to K131457 (Shenzhen Jumper Medical Equipment Co., Ltd., 2014) after a 260-day review. Its family tree reaches back 7 generations to 1994. 4 later devices descend from it.
- Decided
- May 29, 2019
- Review
- 260 days
- Class
- Class II
- Product code
- KNG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K930200 (1994). 4 later devices descend from it, 2 citing it directly.
- 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 deviceK182526 Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B…Vcomin Technology Limited · 2019
- Descendant · cites it directly · 1 of its ownK220245 Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)Contec Medical Systems Co.,Ltd · 2022
- Descendant · cites it directly · 1 of its ownK211940 Fetal DopplerShenzhen Taikang Medical Equipment Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK252669 Fetal Doppler U8-25, U9-25Zhongshan Xiaolan Town Senlan Electronic Factory · 2026
- Descendant · 2 generations on · 0 of its ownK232893 Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC…Contec Medical Systems Co.,Ltd · 2024
Most influential descendants
Showing 4 of 4 · See all- K220245Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)Contec Medical Systems Co.,Ltd · 2022 · cites it directly1descendant
- K211940Fetal DopplerShenzhen Taikang Medical Equipment Co., Ltd. · 2022 · cites it directly1descendant
- K252669Fetal Doppler U8-25, U9-25Zhongshan Xiaolan Town Senlan Electronic Factory · 2026 · 2 generations on0descendants
- K232893Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal…Contec Medical Systems Co.,Ltd · 2024 · 2 generations on0descendants
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) | K182526 | Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D… | Vcomin Technology Limited | 2019 | — |
| +1 | K220245 | Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) | Contec Medical Systems Co.,Ltd | 2022 | — |
| +1 | K211940 | Fetal Doppler | Shenzhen Taikang Medical Equipment Co., Ltd. | 2022 | — |
| +2 | K252669 | Fetal Doppler U8-25, U9-25 | Zhongshan Xiaolan Town Senlan Electronic Factory | 2026 | — |
| +2 | K232893 | Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket… | Contec Medical Systems Co.,Ltd | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K131457 | Fetal Ultrasonic Monitor and AccessoriesSummary page 4…21 CFR 884.2660 Product Code KNG (Monitor, Ultrasonic, Fetal) Regulatory Class II 4. Predicate Device Fetal Doppler (K131457) manufactured by Shenzhen Jumper Medical Equipment Co., Ltd. This predicate has not been subject to any design related recalls.… | 2014 |
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 25 years and passes through 8 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K220245 (Contec Medical Systems Co.,Ltd, 2022) has gone furthest, with 1 descendant of its own.
- 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. 2019, 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 device 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182526 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182526: Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182526
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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