510(k) · Cleared
ClearedUltrasonic Tabletop Doppler; Ultrasonic Tabletop Doppler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edan Instruments, Inc. · MAA Monitor, Fetal Doppler Ultrasound
Cleared on Oct 28, 2010 as substantially equivalent to K942441 (Imex Medical Systems, Inc., 1994) and 2 other predicates after a 90-day review. Its family tree reaches back 5 generations to 1994. 5 later devices descend from it.
- Decided
- Oct 28, 2010
- Review
- 90 days
- Class
- Class II
- Product code
- MAA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K930200 (1994). 9 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK930200 Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc. · 1994
- 4 generations backK991441 Cadence Doppler Ultrasound SystemMedasonics, Inc. · 1999
- 3 generations backK024197 Lifedop DopplerSummit Doppler Systems, Inc. · 2003 · Recalled
- 2 generations backK080087 Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite…Edan Instruments, Inc. · 2008
- 1 generation backK092997 Ultrasonic Tabletop Doppler, Models SD5 and SD6Edan Instruments, Inc. · 2009
- This deviceK102138 Ultrasonic Tabletop Doppler; Ultrasonic Tabletop DopplerEdan Instruments, Inc. · 2010
- Descendant · cites it directly · 4 of its ownK153475 SD5 & SD6 Ultrasonic Tabletop DopplerEdan Instruments, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK180419 Ultrasonic Doppler (Model YM-2T8)Shenzhen Imdk Medical Technology Co., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK212084 Fetal DopplerShenzhen Mericonn Technology Co., Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK182710 Fetal Doppler, Model FD88Shenzzhen Luckcome Technology Inc., Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK182190 Fetal DopplerShenzhen AOJ Medical Technology Co., Ltd. · 2018
Most influential descendants
Showing 5 of 5 · See all- K153475SD5 & SD6 Ultrasonic Tabletop DopplerEdan Instruments, Inc. · 2016 · cites it directly4descendants
- K180419Ultrasonic Doppler (Model YM-2T8)Shenzhen Imdk Medical Technology Co., Ltd. · 2018 · 2 generations on2descendants
- K212084Fetal DopplerShenzhen Mericonn Technology Co., Ltd. · 2021 · 2 generations on0descendants
- K182710Fetal Doppler, Model FD88Shenzzhen Luckcome Technology Inc., Ltd. · 2019 · 3 generations on0descendants
- K182190Fetal DopplerShenzhen AOJ Medical Technology Co., Ltd. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930200 | Multi Dopplex II / Fetal Dopplex II | Huntleigh Healthcare, Inc. | 1994 | — |
| −4 | K991441 | Cadence Doppler Ultrasound System | Medasonics, Inc. | 1999 | — |
| −3 | K024197 | Lifedop Doppler | Summit Doppler Systems, Inc. | 2003 | 1 |
| −2 | K080087 | Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic… | Edan Instruments, Inc. | 2008 | — |
| −1 | K092997 | Ultrasonic Tabletop Doppler, Models SD5 and SD6 | Edan Instruments, Inc. | 2009 | — |
| 0 (this device) | K102138 | Ultrasonic Tabletop Doppler; Ultrasonic Tabletop Doppler | Edan Instruments, Inc. | 2010 | — |
| +1 | K153475 | SD5 & SD6 Ultrasonic Tabletop Doppler | Edan Instruments, Inc. | 2016 | — |
| +2 | K180419 | Ultrasonic Doppler (Model YM-2T8) | Shenzhen Imdk Medical Technology Co., Ltd. | 2018 | — |
| +2 | K212084 | Fetal Doppler | Shenzhen Mericonn Technology Co., Ltd. | 2021 | — |
| +3 | K182710 | Fetal Doppler, Model FD88 | Shenzzhen Luckcome Technology Inc., Ltd. | 2019 | — |
| +3 | K182190 | Fetal Doppler | Shenzhen AOJ Medical Technology Co., Ltd. | 2018 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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 MAA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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…Edan Instruments,In Manufaturer Systems, Inc EaIntuesnc Inc _K# _____K942441 K080087 K092997 Device Description: Ultrasonic TableTop Doppler provide… | 1994 |
| * | K080087 | Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic, Pro, II, II…Summary page 1…Edan Instruments,In Manufaturer Systems, Inc EaIntuesnc Inc _K# _____K942441 K080087 K092997 Device Description: Ultrasonic TableTop Doppler provides the following primary features:… | 2008 |
| * | K092997 | Ultrasonic Tabletop Doppler, Models SD5 and SD6Summary page 1…uments,In Manufaturer Systems, Inc EaIntuesnc Inc _K# _____K942441 K080087 K092997 Device Description: Ultrasonic TableTop Doppler provides the following primary features:… | 2009 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153475 | SD5 & SD6 Ultrasonic Tabletop Doppler | 2016 | 4 |
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 16 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K153475 (Edan Instruments, Inc., 2016) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K942441.
How does its category compare?
All MAA devicesMAA Monitor, Fetal Doppler Ultrasound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MAA
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · MAA
Too few MAA 510(k)s in any year since 2007 to give a median.
Recalls per year · MAA
No recall names MAA since 2007.
Adverse event reports per year · MAA
No MAUDE report names MAA since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Ultrasonic TableTop Doppler is intended to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices. The 2 MHz and/or 3 MHz probes are indicated for the detection of fetal heart rate from early gestation through delivery and as a general indication of fetal well being. They can also…
Read the full statement (109 words)
The Ultrasonic TableTop Doppler is intended to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices.
The 2 MHz and/or 3 MHz probes are indicated for the detection of fetal heart rate from early gestation through delivery and as a general indication of fetal well being. They can also be used to verify fetal heart viability following patient trauma.
The 4 MHz, 5 MHz and/or 8 MHz vascular probes are indicated for the detection of blood flow in veins and arteries 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/K102138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102138: Ultrasonic Tabletop Doppler; Ultrasonic Tabletop Doppler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102138
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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