510(k) · Cleared
ClearedEcho Sounder, ES-102EX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Koven Technology, Inc. · KNG Monitor, Ultrasonic, Fetal
Cleared on Dec 19, 2002 as substantially equivalent to K942441 (Imex Medical Systems, Inc., 1994) and 2 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Dec 19, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- KNG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K930200 (1994). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK930200 Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc. · 1994
- 1 generation backK991441 Cadence Doppler Ultrasound SystemMedasonics, Inc. · 1999
- This deviceK023143 Echo Sounder, ES-102EXKoven Technology, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK031504 Echo Sounder, Single-Handed, Model ES-101EXKoven Technology, Inc. · 2003
Most influential descendants
Showing 1 of 1 · See all- K031504Echo Sounder, Single-Handed, Model ES-101EXKoven Technology, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930200 | Multi Dopplex II / Fetal Dopplex II | Huntleigh Healthcare, Inc. | 1994 | — |
| −1 | K991441 | Cadence Doppler Ultrasound System | Medasonics, Inc. | 1999 | — |
| 0 (this device) | K023143 | Echo Sounder, ES-102EX | Koven Technology, Inc. | 2002 | — |
| +1 | K031504 | Echo Sounder, Single-Handed, Model ES-101EX | Koven Technology, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 13.1 · 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? (3)
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 |
|---|---|---|---|
| * | K942441 | Imexdop CT+Summary page 1…tal ultrasonic monitor and accessories Manufactured by: Hadeco, Hayashi Denki Co., Ltd., Japan 3. Predicate Device(s): K942441, IMEXDOP CT+, IMEX Medical Systems, lnc., Golden, CO 80403. K991441, Cadence Doppler Ultrasound System, Medasonics, Inc… | 1994 |
| * | K991441 | Cadence Doppler Ultrasound SystemSummary page 1…Hadeco, Hayashi Denki Co., Ltd., Japan 3. Predicate Device(s): K942441, IMEXDOP CT+, IMEX Medical Systems, lnc., Golden, CO 80403. K991441, Cadence Doppler Ultrasound System, Medasonics, Inc. K010889, Baby Dopplex 3000 MK 2, Huntleigh Healthcare, Inc., UK… | 1999 |
| * | K010889 | Baby Dopplex 3000 MK 2 (BD3000)Summary page 1…evice(s): K942441, IMEXDOP CT+, IMEX Medical Systems, lnc., Golden, CO 80403. K991441, Cadence Doppler Ultrasound System, Medasonics, Inc. K010889, Baby Dopplex 3000 MK 2, Huntleigh Healthcare, Inc., UK 4. Classifications Names & Citations: Class II per 21… | 2001 |
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 |
|---|---|---|---|
| K031504 | Echo Sounder, Single-Handed, Model ES-101EX | 2003 | 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 8 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K031504 (Koven Technology, Inc., 2003) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K942441.
How does its category compare?
All KNG devicesKNG Monitor, Ultrasonic, Fetal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Detection of fetal heart rate, detection of multiple pregnancies. Veri@ fetal heart viability following patient trauma. Display of fetal heart rate, monitor fetal heart rate during labor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023143 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023143: Echo Sounder, ES-102EX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023143
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