510(k) · Cleared
ClearedFetal Doppler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Mericonn Technology Co., Ltd. · KNG Monitor, Ultrasonic, Fetal
Cleared on Nov 3, 2021 as substantially equivalent to K153475 (Edan Instruments, Inc., 2016) after a 124-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Nov 3, 2021
- Review
- 124 days
- Class
- Class II
- Product code
- KNG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K930200 (1994). 11 ancestors in all. No later device cites it as a predicate yet.
- 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 backK080087 Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite…Edan Instruments, Inc. · 2008
- 3 generations backK092997 Ultrasonic Tabletop Doppler, Models SD5 and SD6Edan Instruments, Inc. · 2009
- 2 generations backK102138 Ultrasonic Tabletop Doppler; Ultrasonic Tabletop DopplerEdan Instruments, Inc. · 2010
- 1 generation backK153475 SD5 & SD6 Ultrasonic Tabletop DopplerEdan Instruments, Inc. · 2016
- This deviceK212084 Fetal DopplerShenzhen Mericonn Technology Co., Ltd. · 2021
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 | K080087 | Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic… | Edan Instruments, Inc. | 2008 | — |
| −3 | K092997 | Ultrasonic Tabletop Doppler, Models SD5 and SD6 | Edan Instruments, Inc. | 2009 | — |
| −2 | K102138 | Ultrasonic Tabletop Doppler; Ultrasonic Tabletop Doppler | Edan Instruments, Inc. | 2010 | — |
| −1 | K153475 | SD5 & SD6 Ultrasonic Tabletop Doppler | Edan Instruments, Inc. | 2016 | — |
| 0 (this device) | K212084 | Fetal Doppler | Shenzhen Mericonn Technology Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K153475 | SD5 & SD6 Ultrasonic Tabletop DopplerSummary page 4…monitor and accessories Regulation Number: 21 CFR 884.2660 Product Code KNG 4. Predicate Device EDAN Instruments, Inc, SD5 Ultrasonic Tabletop Doppler (K153475) The predicate device has not been subject to a design-related recall 5. Device Description Fetal Doppler is intended to detect… | 2016 |
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 27 years and passes through 5 companies; a new generation was cleared every 5.2 years on median.
- 1 of the 11 ancestors has a recall of any class.
- 1 other device also cites its predicate K153475.
How does its category compare?
All KNG devicesKNG Monitor, Ultrasonic, Fetal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Fetal Doppler is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound. Fetal Doppler is indicated for use by health care professionals in hospital, clinic, community and home for singleton pregnancies after 12 weeks gestation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212084 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212084: Fetal Doppler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212084
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