510(k) · Cleared
ClearedHandydop
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elcat, GmbH · KNG Monitor, Ultrasonic, Fetal
Cleared on Sep 12, 2003 as substantially equivalent to K991441 (Medasonics, Inc., 1999) after a 212-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Sep 12, 2003
- Review
- 212 days
- Class
- Class II
- Product code
- KNG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K930200 (1994). 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 deviceK030466 HandydopElcat, GmbH · 2003
- Descendant · cites it directly · 0 of its ownK060064 StethofluxOdvi · 2006
Most influential descendants
Showing 1 of 1 · See all- K060064StethofluxOdvi · 2006 · 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) | K030466 | Handydop | Elcat, GmbH | 2003 | — |
| +1 | K060064 | Stethoflux | Odvi | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 |
|---|---|---|---|
| * | K991441 | Cadence Doppler Ultrasound SystemSummary page 1…SONIC, FETAL IS-Su tjstantial Equivalency is claimed against the following device: ilfedasonics ' Cadence Doppler Ultrasound System, 51 Ok #k991441 (refer to Appendix 2 f o r FDA website printout) This notification for HANDYDOP is o f the AB… | 1999 |
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 |
|---|---|---|---|
| K060064 | Stethoflux | 2006 | 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?
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?
HandyDop™ is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, by means of continuous wave (doppler) echoscopy. The device is indicated for use to detect the flow of blood within the body.
When using it with the 2 MHz probe, HandyDop™ is indicated for use for the early detection of fetal life, detection of multiple pregnancies, fetal screening from early gestation through delivery, and general indication of fetal well being
When using it with the 4 MHz or 8 MHz probes, HandyDop™ is indicated for use for detection of blood flow in the peripheral vascular system for assisting in the detection of peripheral vascular disease
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K030466 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030466: Handydop.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030466
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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