510(k) · Cleared
ClearedFetal Monitor, Models BT-300 and BT-200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bistos Co., Ltd. · HGM System, Monitoring, Perinatal
Cleared on Oct 4, 2005 as substantially equivalent to K994008 (Biosys Co., Ltd., 2000) and 1 other predicate after a 54-day review. Its family tree reaches back 3 generations to 1994. 3 later devices descend from it.
- Decided
- Oct 4, 2005
- Review
- 54 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K930200 (1994). 8 ancestors in all. 3 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 backK040480 Sonotrax Ultrasonic Pocket DopplerEdan Instruments, Inc. · 2004
- This deviceK052190 Fetal Monitor, Models BT-300 and BT-200Bistos Co., Ltd. · 2005
- Descendant · cites it directly · 1 of its ownK100885 Fetal Monitor Model: BT-200TBistos Co., Ltd. · 2010
- Descendant · 2 generations on · 0 of its ownK142799 Model BT-220L and BT-220CBistos Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK110630 F10Mediana Co., Ltd. · 2011
Most influential descendants
Showing 3 of 3 · See allView 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 | K040480 | Sonotrax Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2004 | — |
| 0 (this device) | K052190 | Fetal Monitor, Models BT-300 and BT-200 | Bistos Co., Ltd. | 2005 | — |
| +1 | K100885 | Fetal Monitor Model: BT-200T | Bistos Co., Ltd. | 2010 | — |
| +2 | K142799 | Model BT-220L and BT-220C | Bistos Co., Ltd. | 2015 | — |
| +1 | K110630 | F10 | Mediana Co., Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 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 HGM? 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 HGM device
- #1 K241882 Fetal & Maternal Monitor (F15A, F15A Air)score 19.5 · 33 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K994008 | Biosys Fetal Monitor, Model Ifm-500Summary page 1…ces Manufacturer :BiOSYS Co., Ltd. Device .IFM-500 Ultrasound Fetal Monitor 510(k) Number :K994008(Decisiofl Date - Sep. 29. 2000) Manufacturer :Edan Instruments, Inc. Device… | 2000 |
| * | K040480 | Sonotrax Ultrasonic Pocket DopplerSummary page 1…Manufacturer :Edan Instruments, Inc. Device Sonotrax Ultrasonic Pocket Doppler 510(k) Number :K040480(Decision Date - May. 25. 2004) 4. Classifications Names & Citations: 21CFR 884.2740, HGM, System, Monitoring, Perinat… | 2004 |
What descends from it? (3)
2 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 11 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K100885 (Bistos Co., Ltd., 2010) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K994008.
How does its category compare?
All HGM devicesHGM System, Monitoring, Perinatal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HGM
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HGM
269in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HGM
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HGM
99in 2025
MAUDE reports naming product code HGM, 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 | 3 | 56 | 0 | 35 |
| 2008 | 4 | 75 | 4 | 17 |
| 2009 | 4 | 66 | 6 | 42 |
| 2010 | 4 | 193 | 0 | 64 |
| 2011 | 13 | 141 | 0 | 83 |
| 2012 | 4 | 107 | 0 | 44 |
| 2013 | 2 | — | 1 | 16 |
| 2014 | 4 | 231 | 1 | 30 |
| 2015 | 5 | 169 | 0 | 44 |
| 2016 | 1 | — | 0 | 17 |
| 2017 | 3 | 138 | 0 | 27 |
| 2018 | 3 | 258 | 0 | 30 |
| 2019 | 0 | — | 5 | 41 |
| 2020 | 1 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 71 |
| 2022 | 1 | — | 0 | 87 |
| 2023 | 2 | — | 0 | 69 |
| 2024 | 1 | — | 0 | 174 |
| 2025 | 4 | 269 | 0 | 99 |
| 2026 | 2 | — | 2 | — |
What is it indicated for?
The BT-300 Fetal Monitor for measuring and recording maternal contraction and fetal heart rate. Data is displayed on a front panel 7-segment LED Display, recorded on a strip chart recorder and may be transmitted over telephone lines to a remote data receiver. Single/Twin fetal heart rates may be measured by means of Doppler Ultrasound. Uterine Activity is measured with an external TOCO transducer.
The BT200 is a Fetal Monitor for measuring fetal heart rate. Data is displayed on a front panel LCD Display. Fetal heart rate may be measured by means of Doppler Ultrasound.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052190 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052190: Fetal Monitor, Models BT-300 and BT-200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052190
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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