510(k) · Cleared
ClearedEcho Sounder, Single-Handed, Model ES-101EX
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 Jul 18, 2003 as substantially equivalent to K023143 (Koven Technology, Inc., 2002) after a 65-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Jul 18, 2003
- Review
- 65 days
- Class
- Class II
- Product code
- KNG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K930200 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK930200 Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc. · 1994
- 2 generations backK991441 Cadence Doppler Ultrasound SystemMedasonics, Inc. · 1999
- 1 generation backK023143 Echo Sounder, ES-102EXKoven Technology, Inc. · 2002
- This deviceK031504 Echo Sounder, Single-Handed, Model ES-101EXKoven Technology, Inc. · 2003
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 | K023143 | Echo Sounder, ES-102EX | Koven Technology, Inc. | 2002 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K023143 | Echo Sounder, ES-102EX | 2002 |
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 9 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 5 ancestors has a recall.
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 life, detection of multiple pregnancies, fetal screens from early gestation through delivery and general indication of fetal well being. Verify fetal heart viability following patient trauma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031504 · printed Nov 4, 2026
Cite this page
510(k) Report. “K031504: Echo Sounder, Single-Handed, Model ES-101EX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K031504
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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