510(k) · Cleared
ClearedContec Pocket Fetal Doppler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Contec Medical System Co., Ltd. · KNG Monitor, Ultrasonic, Fetal
Cleared on Feb 25, 2009 as substantially equivalent to K024197 (Summit Doppler Systems, Inc., 2003) after a 181-day review. Its family tree reaches back 3 generations to 1994. 12 later devices descend from it.
- Decided
- Feb 25, 2009
- Review
- 181 days
- Class
- Class II
- Product code
- KNG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K930200 (1994). 12 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK930200 Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc. · 1994
- 2 generations backK991441 Cadence Doppler Ultrasound SystemMedasonics, Inc. · 1999
- 1 generation backK024197 Lifedop DopplerSummit Doppler Systems, Inc. · 2003 · Recalled
- This deviceK082480 Contec Pocket Fetal DopplerContec Medical System Co., Ltd. · 2009
- Descendant · cites it directly · 9 of its ownK100626 Doppler Fetal Heart Rate Detector, Model FM-200Shenzhen Biocare Electronics Co., Ltd. · 2010
- Descendant · 2 generations on · 8 of its ownK112911 Fetal DopplerBeijing Choice Electronic Technololgy Co., Ltd. · 2011
- Descendant · 3 generations on · 6 of its ownK131457 Fetal Ultrasonic Monitor and AccessoriesShenzhen Jumper Medical Equipment Co., Ltd. · 2014
- Descendant · 4 generations on · 4 of its ownK182526 Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B…Vcomin Technology Limited · 2019
- Descendant · 5 generations on · 1 of its ownK220245 Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)Contec Medical Systems Co.,Ltd · 2022
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K100626Doppler Fetal Heart Rate Detector, Model FM-200Shenzhen Biocare Electronics Co., Ltd. · 2010 · cites it directly9descendants
- K112911Fetal DopplerBeijing Choice Electronic Technololgy Co., Ltd. · 2011 · 2 generations on8descendants
- K131457Fetal Ultrasonic Monitor and AccessoriesShenzhen Jumper Medical Equipment Co., Ltd. · 2014 · 3 generations on6descendants
- K182526Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B…Vcomin Technology Limited · 2019 · 4 generations on4descendants
- K220245Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)Contec Medical Systems Co.,Ltd · 2022 · 5 generations on1descendant
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 | K024197 | Lifedop Doppler | Summit Doppler Systems, Inc. | 2003 | 1 |
| 0 (this device) | K082480 | Contec Pocket Fetal Doppler | Contec Medical System Co., Ltd. | 2009 | — |
| +1 | K100626 | Doppler Fetal Heart Rate Detector, Model FM-200 | Shenzhen Biocare Electronics Co., Ltd. | 2010 | — |
| +2 | K112911 | Fetal Doppler | Beijing Choice Electronic Technololgy Co., Ltd. | 2011 | — |
| +3 | K131457 | Fetal Ultrasonic Monitor and Accessories | Shenzhen Jumper Medical Equipment Co., Ltd. | 2014 | — |
| +4 | K182526 | Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D… | Vcomin Technology Limited | 2019 | — |
| +5 | K220245 | Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) | Contec Medical Systems Co.,Ltd | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K024197 | Lifedop DopplerSummary page 2…and Baby Sound B are integrated with 2MHz probe. Predicate Device LifeDop Doppler Ultrasound System K-number: K024197 Product Code: KNG Intended Use: The LifeDo… | 2003 |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K100626 (Shenzhen Biocare Electronics Co., Ltd., 2010) has gone furthest, with 9 descendants of its own.
- 6 other devices also cite its predicate K024197.
How does its category compare?
All KNG devicesKNG Monitor, Ultrasonic, Fetal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Contect Pocket Fetal Doppler (SONOLINE A, SONOLINE B, Baby Sound A and Baby Sound B) are hand-held, battery powered audio Doppler devices used for detecting fetal heart beats. They are all available for user replaceable batteries. The user interface includes power button, mode button, volume control, single speaker, headphone jack and LCD display for heart rate, battery and working mode, probe type.
SONOLINE A and SONOLINE B includes four interchangeable probes (2MHz normal probe,2Mlz water proof probe,3MHz normal probe,3'Ml-lz water proof probe), while Baby Sound A and Baby Sound B are integrated with 2MHz probe.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082480 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082480: Contec Pocket Fetal Doppler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082480
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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