510(k) · Cleared
ClearedF10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mediana Co., Ltd. · KNG Monitor, Ultrasonic, Fetal
Cleared on Jun 24, 2011 as substantially equivalent to K040480 (Edan Instruments, Inc., 2004) and 1 other predicate after a 113-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Jun 24, 2011
- Review
- 113 days
- Class
- Class II
- Product code
- KNG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K930200 (1994). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK930200 Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc. · 1994
- 3 generations backK991441 Cadence Doppler Ultrasound SystemMedasonics, Inc. · 1999
- 2 generations backK040480 Sonotrax Ultrasonic Pocket DopplerEdan Instruments, Inc. · 2004
- 1 generation backK052190 Fetal Monitor, Models BT-300 and BT-200Bistos Co., Ltd. · 2005
- This deviceK110630 F10Mediana Co., Ltd. · 2011
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 | K040480 | Sonotrax Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2004 | — |
| −1 | K052190 | Fetal Monitor, Models BT-300 and BT-200 | Bistos Co., Ltd. | 2005 | — |
| 0 (this device) | K110630 | F10 | Mediana Co., Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 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? (2)
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 1…e predicate devices for Fetal Doppler, Model F1l0 are: * Edan Instruments, Inc. Ultrasonic Pocket Doppler, Sonotrax cleared by FDA through 510(k) No. K040480 (Decision Date -May.25. 2004), and * Bistos Co., Ltd. Ultrasonic Pocket Doppler, BT-200… | 2004 |
| * | K052190 | Fetal Monitor, Models BT-300 and BT-200 | 2005 |
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 17 years and passes through 5 companies; a new generation was cleared every 5.5 years on median.
- None of the 9 ancestors has a recall.
- 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. 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 F10 Fetal Doppler measures heart rate, which is displayed on a LCD display and provides fetal heart sounds. The fetal heart rate is measured using Doppler ultrasound.
Intended use : Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110630 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110630: F10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110630
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