510(k) · Cleared
ClearedFetal Monitor Model: BT-200T
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 Jun 7, 2010 as substantially equivalent to K052190 (Bistos Co., Ltd., 2005) after a 69-day review. Its family tree reaches back 4 generations to 1994. 1 later device descends from it.
- Decided
- Jun 7, 2010
- Review
- 69 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K930200 (1994). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK930200 Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc. · 1994
- 3 generations backK991441 Cadence Doppler Ultrasound SystemMedasonics, Inc. · 1999
- 2 generations backK040480 Sonotrax Ultrasonic Pocket DopplerEdan Instruments, Inc. · 2004
- 1 generation backK052190 Fetal Monitor, Models BT-300 and BT-200Bistos Co., Ltd. · 2005
- This deviceK100885 Fetal Monitor Model: BT-200TBistos Co., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK142799 Model BT-220L and BT-220CBistos Co., Ltd. · 2015
Most influential descendants
Showing 1 of 1 · See all- K142799Model BT-220L and BT-220CBistos Co., Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930200 | Multi Dopplex II / Fetal Dopplex II | Huntleigh Healthcare, Inc. | 1994 | — |
| −3 | K991441 | Cadence Doppler Ultrasound System | Medasonics, Inc. | 1999 | — |
| −2 | K040480 | Sonotrax Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2004 | — |
| −1 | K052190 | Fetal Monitor, Models BT-300 and BT-200 | Bistos Co., Ltd. | 2005 | — |
| 0 (this device) | K100885 | Fetal Monitor Model: BT-200T | Bistos Co., Ltd. | 2010 | — |
| +1 | K142799 | Model BT-220L and BT-220C | Bistos Co., Ltd. | 2015 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K052190 | Fetal Monitor, Models BT-300 and BT-200Summary page 3…usion Bistos' BT-200T Pocket size Petal monitor in this submission is substantially equivalent to the already cleared BT-200 under K052 190 on Oct 2005 at Design, specification, intended use, used material, direction to use, software,… | 2005 |
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 |
|---|---|---|---|
| K142799 | Model BT-220L and BT-220C | 2015 | 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?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K142799 (Bistos Co., Ltd., 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K052190.
How does its category compare?
All HGM devicesHGM System, Monitoring, Perinatal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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-200T is a Fetal Monitor for measuring Fetal Heart Rate, Data is displayed on a front panel LCD display, Fetal heart may be measured by means of Doppler ultrasound.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100885 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100885: Fetal Monitor Model: BT-200T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100885
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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