510(k) · Cleared
ClearedDoppler Fetal Heart Rate Detector, Model FM-200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Biocare Electronics Co., Ltd. · KNG Monitor, Ultrasonic, Fetal
Cleared on May 21, 2010 as substantially equivalent to K082480 (Contec Medical System Co., Ltd., 2009) after a 77-day review. Its family tree reaches back 4 generations to 1994. 9 later devices descend from it.
- Decided
- May 21, 2010
- Review
- 77 days
- Class
- Class II
- Product code
- KNG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K930200 (1994). 9 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK930200 Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc. · 1994
- 3 generations backK991441 Cadence Doppler Ultrasound SystemMedasonics, Inc. · 1999
- 2 generations backK024197 Lifedop DopplerSummit Doppler Systems, Inc. · 2003 · Recalled
- 1 generation backK082480 Contec Pocket Fetal DopplerContec Medical System Co., Ltd. · 2009
- This deviceK100626 Doppler Fetal Heart Rate Detector, Model FM-200Shenzhen Biocare Electronics Co., Ltd. · 2010
- Descendant · cites it directly · 8 of its ownK112911 Fetal DopplerBeijing Choice Electronic Technololgy Co., Ltd. · 2011
- Descendant · 2 generations on · 6 of its ownK131457 Fetal Ultrasonic Monitor and AccessoriesShenzhen Jumper Medical Equipment Co., Ltd. · 2014
- Descendant · 3 generations on · 4 of its ownK182526 Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B…Vcomin Technology Limited · 2019
- Descendant · 4 generations on · 1 of its ownK220245 Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)Contec Medical Systems Co.,Ltd · 2022
- Descendant · 4 generations on · 1 of its ownK211940 Fetal DopplerShenzhen Taikang Medical Equipment Co., Ltd. · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K112911Fetal DopplerBeijing Choice Electronic Technololgy Co., Ltd. · 2011 · cites it directly8descendants
- K131457Fetal Ultrasonic Monitor and AccessoriesShenzhen Jumper Medical Equipment Co., Ltd. · 2014 · 2 generations on6descendants
- K182526Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B…Vcomin Technology Limited · 2019 · 3 generations on4descendants
- K220245Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)Contec Medical Systems Co.,Ltd · 2022 · 4 generations on1descendant
- K211940Fetal DopplerShenzhen Taikang Medical Equipment Co., Ltd. · 2022 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930200 | Multi Dopplex II / Fetal Dopplex II | Huntleigh Healthcare, Inc. | 1994 | — |
| −3 | K991441 | Cadence Doppler Ultrasound System | Medasonics, Inc. | 1999 | — |
| −2 | K024197 | Lifedop Doppler | Summit Doppler Systems, Inc. | 2003 | 1 |
| −1 | K082480 | Contec Pocket Fetal Doppler | Contec Medical System Co., Ltd. | 2009 | — |
| 0 (this device) | K100626 | Doppler Fetal Heart Rate Detector, Model FM-200 | Shenzhen Biocare Electronics Co., Ltd. | 2010 | — |
| +1 | K112911 | Fetal Doppler | Beijing Choice Electronic Technololgy Co., Ltd. | 2011 | — |
| +2 | K131457 | Fetal Ultrasonic Monitor and Accessories | Shenzhen Jumper Medical Equipment Co., Ltd. | 2014 | — |
| +3 | K182526 | Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D… | Vcomin Technology Limited | 2019 | — |
| +4 | K220245 | Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) | Contec Medical Systems Co.,Ltd | 2022 | — |
| +4 | K211940 | Fetal Doppler | Shenzhen Taikang Medical Equipment Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K082480 | Contec Pocket Fetal DopplerSummary page 1…New Device Submission Type Traditional 5 10O(k) Predicate Device: Contec Pocket Petal Doppler K082480 Intended Use FM-200 Doppler Fetal Heart Rate Detector is a band-held, battery… | 2009 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112911 | Fetal Doppler | 2011 | 8 |
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 16 years and passes through 5 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K112911 (Beijing Choice Electronic Technololgy Co., Ltd., 2011) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K082480.
How does its category compare?
All KNG devicesKNG Monitor, Ultrasonic, Fetal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
FM-200 Doppler Fetal Heart Rate Detector is a hand-held, battery powered Doppler devices used for detecting fetal heart beats.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100626: Doppler Fetal Heart Rate Detector, Model FM-200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100626
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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