510(k) · Cleared
ClearedDoppler Fetal Heartbeat Rate Detector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Bestman Instrument Co., Ltd. · KNG Monitor, Ultrasonic, Fetal
Cleared on Apr 29, 2010 as substantially equivalent to K040480 (Edan Instruments, Inc., 2004) after a 427-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- Apr 29, 2010
- Review
- 427 days
- Class
- Class II
- Product code
- KNG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K930200 (1994). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK930200 Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc. · 1994
- 2 generations backK991441 Cadence Doppler Ultrasound SystemMedasonics, Inc. · 1999
- 1 generation backK040480 Sonotrax Ultrasonic Pocket DopplerEdan Instruments, Inc. · 2004
- This deviceK090510 Doppler Fetal Heartbeat Rate DetectorShenzhen Bestman Instrument Co., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK242846 Doppler FHR Detector (BF-500D+, BF-560)Shenzhen Bestman Instrument Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K242846Doppler FHR Detector (BF-500D+, BF-560)Shenzhen Bestman Instrument Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930200 | Multi Dopplex II / Fetal Dopplex II | Huntleigh Healthcare, Inc. | 1994 | — |
| −2 | K991441 | Cadence Doppler Ultrasound System | Medasonics, Inc. | 1999 | — |
| −1 | K040480 | Sonotrax Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2004 | — |
| 0 (this device) | K090510 | Doppler Fetal Heartbeat Rate Detector | Shenzhen Bestman Instrument Co., Ltd. | 2010 | — |
| +1 | K242846 | Doppler FHR Detector (BF-500D+, BF-560) | Shenzhen Bestman Instrument Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K040480 | Sonotrax Ultrasonic Pocket DopplerSummary page 2…* Product Code: KNG 510 (k) Summary 0 Manufactured By: Shenzhen BestmanlInstrument Co., Ltd., China 3. Predicate Device: K040480 SONOTRAX 4. Classification Names: Class II as per 21ICFR 884-2660, Ultrasonic Fetal Monitor and accessories. 5. Descript… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242846 | Doppler FHR Detector (BF-500D+, BF-560) | 2025 | 0 |
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 4 companies; a new generation was cleared every 5.5 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K242846 (Shenzhen Bestman Instrument Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K040480.
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?
This Doppler can be used for the detection of average fetal heartbeat rate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090510 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090510: Doppler Fetal Heartbeat Rate Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090510
Report an extraction error
Are you the manufacturer?
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