510(k) · Cleared
ClearedBiosys Fetal Monitor, Model Ifm-500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosys Co., Ltd. · HGM System, Monitoring, Perinatal
Cleared on Sep 29, 2000 as substantially equivalent to K934959 (Ge Medical Systems Information Technologies, 1994) after a 310-day review. Its family tree reaches back 1 generation to 1994. 6 later devices descend from it.
- Decided
- Sep 29, 2000
- Review
- 310 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934959 (1994). 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK934959 Model 118 Fetal/Maternal MonitorGe Medical Systems Information Technologies · 1994
- This deviceK994008 Biosys Fetal Monitor, Model Ifm-500Biosys Co., Ltd. · 2000
- Descendant · cites it directly · 3 of its ownK052190 Fetal Monitor, Models BT-300 and BT-200Bistos Co., Ltd. · 2005
- Descendant · 2 generations on · 1 of its ownK100885 Fetal Monitor Model: BT-200TBistos Co., Ltd. · 2010
- Descendant · 3 generations on · 0 of its ownK142799 Model BT-220L and BT-220CBistos Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK110612 FM20Mediana Co., Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK110630 F10Mediana Co., Ltd. · 2011
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K052190Fetal Monitor, Models BT-300 and BT-200Bistos Co., Ltd. · 2005 · cites it directly3descendants
- K100885Fetal Monitor Model: BT-200TBistos Co., Ltd. · 2010 · 2 generations on1descendant
- K142799Model BT-220L and BT-220CBistos Co., Ltd. · 2015 · 3 generations on0descendants
- K110612FM20Mediana Co., Ltd. · 2011 · cites it directly0descendants
- K110630F10Mediana Co., Ltd. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934959 | Model 118 Fetal/Maternal Monitor | Ge Medical Systems Information Technologies | 1994 | — |
| 0 (this device) | K994008 | Biosys Fetal Monitor, Model Ifm-500 | Biosys Co., Ltd. | 2000 | — |
| +1 | K052190 | Fetal Monitor, Models BT-300 and BT-200 | Bistos Co., Ltd. | 2005 | — |
| +2 | K100885 | Fetal Monitor Model: BT-200T | Bistos Co., Ltd. | 2010 | — |
| +3 | K142799 | Model BT-220L and BT-220C | Bistos Co., Ltd. | 2015 | — |
| +1 | K110612 | FM20 | Mediana Co., Ltd. | 2011 | — |
| +2 | K110630 | F10 | Mediana Co., Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 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? (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 |
|---|---|---|---|
| * | K934959 | Model 118 Fetal/Maternal MonitorSummary page 3…mmary of the safety and effectiveness data on which the substantial equivalence determination is based: Predicate Device Comparison Chart Feature IFM-500 Model 118 (K934959) Indication for Use - Fetal (perinatal fetal monitor) - Fetal (perinatal fetal monitor) - Maternal monitor Modes of Operation… | 1994 |
What descends from it? (6)
3 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?
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 IFM-500 is an Perinatal 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 or twin fetal heart rates may be measured by means of Pulsed Doppler Ultrasound. Uterine Activity is measured with an external TOCO transducer.
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/K994008 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994008: Biosys Fetal Monitor, Model Ifm-500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994008
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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